Surveyor Patient Monitor
FDA 510(k) clearance K173765 · decided 2018-09-04
Clearance details
- K-number
- K173765
- Device name
- Surveyor Patient Monitor
- Applicant
- Mortara Instrument, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-11
- Decision date
- 2018-09-04
- Days to decision
- 267 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
+ Add to Predicate Builder ◉ Watch Mortara Instrument
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following dev recall (Z-1816-2020) | WELCH ALLYN, INC/MORTARA | 2020-04-29 |