Datex-Engstrom, Inc.
Medical device manufacturer in Tewksburt, MA.
10510(k) clearances
0PMA approvals
0recalls
Device types
- DSI Detector And Alarm, Arrhythmia 2
- CAH Filter, Bacterial, Breathing-Circuit 1
- MSX System, Network And Communication… 1
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1
- DPS Electrocardiograph 1
- BSZ Gas-Machine, Anesthesia 1
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- MHX Monitor, Physiological, Patient(With… 1
- KNT Tubes, Gastrointestinal (And Accessories) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K983366 | Trip Tonometry Catheter, 16FKNT · Traditional | 12/23/1998SE |
| K982091 | CS/3 Compact Airway Module, M-CovxMHX · Traditional | 12/22/1998SE |
| K981378 | Datex-Engstrom Light Monitor Models F-LM1, F-LMP1DRT · Traditional | 11/03/1998SE |
| K973985 | AS/3 Anaesthesia Delivery Unit (AS/3 Adu)BSZ · Traditional | 10/30/1998SE |
| K980362 | MRI Compatible Monitor and AccessoriesDPS · Traditional | 06/30/1998SE |
| K974792 | CS/3(TM) Monitors*DSI · Traditional | 06/02/1998SE |
| K980384 | Trip Tonometry Catheter, 18FCCK · Traditional | 05/01/1998SE |
| K974747 | CS/3 Arrhythmia WorkstationDSI · Traditional | 04/23/1998SE |
| K974101 | Datex-Engstrom NetworkMSX · Traditional | 02/06/1998SE |
| K964204 | Engstrom Hmef 1000CAH · Traditional | 11/13/1996SE |