FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Surveyor S4 Mobile Monitor
K Number: K160685
·
Decision Aug 4, 2016
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
51
Review Days
146
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Basic Information
- Device Name
- Surveyor S4 Mobile Monitor
- K Number
- K160685
- 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
- March 11, 2016
- Decision Date
- August 4, 2016
- 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 |
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Other Clearances by Mortara Instrument, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182297 | Surveyor S2 | Jan 24, 2019 | Substantially Equivalent |
| K173765 | Surveyor Patient Monitor | Sep 4, 2018 | Substantially Equivalent |
| K161517 | Mortara Surveyor Patient Monitor | Jan 11, 2017 | Substantially Equivalent |
| K161465 | CardioConfirm | Sep 3, 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 |