The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Surveyor S4 Mobile Monitor.
| Device ID | K160685 |
| 510k Number | K160685 |
| Device Name: | Surveyor S4 Mobile 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 |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-11 |
| Decision Date | 2016-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094350920 | K160685 | 000 |
| 00732094296495 | K160685 | 000 |
| 00732094307405 | K160685 | 000 |
| 00732094307849 | K160685 | 000 |
| 00732094307887 | K160685 | 000 |
| 00732094307894 | K160685 | 000 |
| 00732094308389 | K160685 | 000 |
| 00732094308396 | K160685 | 000 |
| 00732094314243 | K160685 | 000 |
| 00732094262865 | K160685 | 000 |
| 00732094262667 | K160685 | 000 |
| 00732094262377 | K160685 | 000 |
| 00732094280364 | K160685 | 000 |
| 00732094262292 | K160685 | 000 |
| 00732094262308 | K160685 | 000 |
| 00732094262315 | K160685 | 000 |
| 00732094262322 | K160685 | 000 |
| 00732094262346 | K160685 | 000 |
| 00732094262353 | K160685 | 000 |
| 00732094262360 | K160685 | 000 |
| 00732094314250 | K160685 | 000 |
| 00732094315585 | K160685 | 000 |
| 00732094315769 | K160685 | 000 |
| 00732094325270 | K160685 | 000 |
| 00732094325287 | K160685 | 000 |
| 00732094262339 | K160685 | 000 |
| 00732094296198 | K160685 | 000 |
| 00732094284744 | K160685 | 000 |
| 00732094320824 | K160685 | 000 |
| 00732094320008 | K160685 | 000 |
| 00732094320084 | K160685 | 000 |
| 00732094325102 | K160685 | 000 |
| 00732094325362 | K160685 | 000 |
| 00732094325874 | K160685 | 000 |
| 00732094317510 | K160685 | 000 |
| 00732094324228 | K160685 | 000 |
| 00732094325669 | K160685 | 000 |
| 00732094328974 | K160685 | 000 |
| 00732094328981 | K160685 | 000 |
| 00732094325843 | K160685 | 000 |
| 00732094325850 | K160685 | 000 |
| 00732094325867 | K160685 | 000 |
| 00732094319064 | K160685 | 000 |