Mortara Instrument, Inc.
Medical device manufacturer in Milwaukee, WI.
51510(k) clearances
0PMA approvals
2recalls
Device types
- DPS Electrocardiograph 21
- MHX Monitor, Physiological, Patient(With… 7
- DSI Detector And Alarm, Arrhythmia 3
- DRG Transmitters And Receivers, Physiological… 3
- MWJ Electrocardiograph, Ambulatory (Without… 3
- DSH Recorder, Magnetic Tape, Medical 2
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- DXJ Display, Cathode-Ray Tube, Medical 1
- MLO Electrocardiograph, Ambulatory, With… 1
- DQA Oximeter 1
- DXN System, Measurement, Blood-Pressure… 1
- DQK Computer, Diagnostic, Programmable 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K182297 | Surveyor S2DRG · Traditional | 01/24/2019SE |
| K173765 | Surveyor Patient MonitorMHX · Traditional | 09/04/2018SE |
| K161517 | Mortara Surveyor Patient MonitorMHX · Traditional | 01/11/2017SE |
| K161465 | CardioConfirmDQK · Traditional | 09/03/2016SE |
| K160685 | Surveyor S4 Mobile MonitorMHX · Traditional | 08/04/2016SE |
| K152626 | H3+ Holter RecorderMWJ · Traditional | 02/26/2016SE |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS · Traditional | 01/06/2016SE |
| K141020 | Surveyor S4 Mobile MonitorDRG · Traditional | 12/03/2014SE |
| K133989 | Ambulo 2400 Ambulatory Blood Pressure Monitoring SystemDXN · Abbreviated | 11/25/2014SE |
| K141811 | Mortara Monitoring Waveform ViewerMHX · Abbreviated | 11/19/2014SE |
| K142105 | Eli 380 ElectrocardiographDPS · Special | 09/05/2014SE |
| K131929 | Surveyor Central StationMHX · Abbreviated | 12/03/2013SE |
| K123556 | Mortara Surveyor Patient MonitorMHX · Abbreviated | 03/22/2013SE |
| K122073 | Eli 280 ElectrocardiographDPS · Special | 08/02/2012SE |
| K120865 | Rscribe ElectrocardiographDPS · Special | 07/19/2012SE |
| K102206 | Eli 10 Electrocardiograph Model Eli 10DPS · Abbreviated | 02/18/2011SE |
| K101403 | Eli 250 ElectrocardiographDPS · Abbreviated | 07/02/2010SE |
| K101115 | Eli 150 Electrocardiograph Model Eli 150DPS · Abbreviated | 06/18/2010SE |
| K100127 | Eli 230 ElectrocardiographDPS · Abbreviated | 04/16/2010SE |
| K093339 | Eli PC ElectrocardiographDPS · Abbreviated | 02/19/2010SE |
| K092663 | Eli 350 ElectrocardiographDPS · Abbreviated | 12/14/2009SE |
| K082946 | Mortara Eli 350 ElectrocardiographDPS · Traditional | 12/29/2008SE |
| K081800 | T12S Telemetry TransmitterDQA · Abbreviated | 09/24/2008SE |
| K070539 | Mortara Eli 10 ElectrocardiographDPS · Special | 03/15/2007SE |
| K062677 | Eli 350 ElectrocardiographDPS · Special | 11/15/2006SE |
| K060135 | Mortara Surveyor Telemetry Central StationMHX · Abbreviated | 05/15/2006SE |
| K050896 | H12+ Holter RecorderDSH · Traditional | 08/24/2005SE |
| K043010 | Holter Recorder H3+MWJ · Abbreviated | 02/25/2005SE |
| K031182 | Eli 200+ AudicorDPS · Traditional | 07/25/2003SE |
| K022618 | X-Scribe IIDPS · Special | 09/06/2002SE |
| K021373 | H12+HOLTER RecorderMWJ · Special | 06/27/2002SE |
| K004017 | H-ScribeMLO · Traditional | 06/11/2001SE |
| K974149 | Ambulatory X-12 Telemetry ModuleDRG · Traditional | 01/08/1998SE |
| K942685 | ECG Review StationDXJ · Traditional | 08/12/1997SE |
| K933143 | Model Eli 300 ElectrocardiographLOS · Traditional | 04/15/1994SE |
| K930558 | Mortara Instrument, Inc. E-ScribeDPS · Traditional | 04/27/1993SE |
| K922927 | Mortara Instrument ST Central StationDPS · Traditional | 11/10/1992SE |
| K915730 | Mortara Instrument Odel Eli 50ILOS · Traditional | 11/10/1992SE |
| K920627 | Model Eli 100 ElectrocardiographLOS · Traditional | 09/04/1992SE |
| K920626 | Model Eli 200 ElectrocardiographLOS · Traditional | 09/04/1992SE |
| K920377 | Mortara Instrument Model ECG PrevuLOS · Traditional | 04/28/1992SE |
| K911097 | PR4DSH · Traditional | 08/07/1991SE |
| K900720 | Mortara Instrument Model X-Scribe (Treadmill Included)DSI · Traditional | 11/05/1990SE |
| K902652 | Mortara Instrument Model Eli 50DRT · Traditional | 08/23/1990SE |
| K895232 | Model ELI-100/ST ElectrocardiographLOS · Traditional | 12/13/1989SE |
| K880664 | Mortara Instrument Model Eli-Xr (Treadmill Included)DSI · Traditional | 03/09/1988SE |
| K864580 | Model EL-1 W/St Monitor Option (Acronym = Eli/Stm)DPS · Traditional | 02/20/1987SE |
| K861851 | Siemens-Elema (Sicard-P)DPS · Traditional | 08/28/1986SE |
| K861850 | Burdick Division (E-500)DPS · Traditional | 08/28/1986SE |
| K851702 | Mortara Instrument Model EL-1DSI · Traditional | 07/29/1985SE |
| K832050 | Mortara Instrument #101DPS · Traditional | 12/13/1983SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1796-2015 Class II | ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance…Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380… | 05/29/2015Terminated |
| Z-0110-2015 Class II | Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are…Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand… | 10/07/2014Terminated |