The following data is part of a premarket notification filed by Mortara Instrument Inc with the FDA for Surveyor S2.
| Device ID | K182297 |
| 510k Number | K182297 |
| Device Name: | Surveyor S2 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Mortara Instrument Inc 7865 North 86th Street Milwaukee, WI 53224 |
| Contact | Marco Manduchi |
| Correspondent | Marco Manduchi Mortara Instrument Inc 7865 North 86th Street Milwaukee, WI 53224 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2019-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094323931 | K182297 | 000 |