Mortara Surveyor Patient Monitor
FDA 510(k) K161517 · Mortara Instrument, Inc.
510(k) numberK161517
Submission
- Device name
- Mortara Surveyor Patient Monitor
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- June 2, 2016
- Decision date
- January 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code MHX
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| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K182297 | Surveyor S2DRG · Traditional | 01/24/2019SE |
| K173765 | Surveyor Patient MonitorMHX · Traditional | 09/04/2018SE |
| 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 |
Questions and answers
When was Mortara Surveyor Patient Monitor cleared by the FDA?
Mortara Surveyor Patient Monitor (K161517) received a 510(k) decision of Substantially Equivalent on January 11, 2017, 223 days after the submission was received.
What is the product code of K161517?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.