The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Surveyor Patient Monitor.
| Device ID | K161517 |
| 510k Number | K161517 |
| Device Name: | Mortara Surveyor Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH STREET Milwaukee, WI 53224 |
| Contact | Sarah Weber |
| Correspondent | Sarah Weber 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 | 2016-06-02 |
| Decision Date | 2017-01-11 |
| Summary: | summary |