The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Surveyor Patient Monitor.
| Device ID | K173765 |
| 510k Number | K173765 |
| Device Name: | Surveyor Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 |
| Contact | Manisha Gokuli |
| Correspondent | Manisha Gokuli Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 |
| Product Code | MHX |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-11 |
| Decision Date | 2018-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094277036 | K173765 | 000 |
| 00732094277029 | K173765 | 000 |