Surveyor S4 Mobile Monitor
FDA 510(k) clearance K160685 · decided 2016-08-04
Clearance details
- K-number
- K160685
- Device name
- Surveyor S4 Mobile Monitor
- Applicant
- Mortara Instrument, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-11
- Decision date
- 2016-08-04
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE recall (Z-1815-2020) | WELCH ALLYN, INC/MORTARA | 2020-04-29 |