FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Surveyor Patient Monitor
K Number: K173765
·
Decision Sep 4, 2018
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
51
Review Days
267
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Surveyor Patient Monitor
- K Number
- K173765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mortara Instrument, Inc.
- Date Received
- December 11, 2017
- Decision Date
- September 4, 2018
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHX), ordered by most recent decision date.
Radius VSM and Accessories
FDA 510(k)
FDA Class 2
·Cardiovascular
M12 Telemetry System
FDA 510(k)
FDA Class 2
·Cardiovascular
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
FDA 510(k)
FDA Class 2
·Cardiovascular
Vista CMS
FDA 510(k)
FDA Class 2
·Cardiovascular
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Mortara Instrument, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182297 | Surveyor S2 | Jan 24, 2019 | Substantially Equivalent |
| K161517 | Mortara Surveyor Patient Monitor | Jan 11, 2017 | Substantially Equivalent |
| K161465 | CardioConfirm | Sep 3, 2016 | Substantially Equivalent |
| K160685 | Surveyor S4 Mobile Monitor | Aug 4, 2016 | Substantially Equivalent |
| K152626 | H3+ Holter Recorder | Feb 26, 2016 | Substantially Equivalent |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | Jan 6, 2016 | Substantially Equivalent |
| K141020 | SURVEYOR S4 MOBILE MONITOR | Dec 3, 2014 | Substantially Equivalent |
| K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | Nov 25, 2014 | Substantially Equivalent |
| K141811 | MORTARA MONITORING WAVEFORM VIEWER | Nov 19, 2014 | Substantially Equivalent |
| K142105 | ELI 380 ELECTROCARDIOGRAPH | Sep 5, 2014 | Substantially Equivalent |