The following data is part of a premarket notification filed by Centurion Medical Products Corporation with the FDA for Compass Cast And Map.
| Device ID | K161408 |
| 510k Number | K161408 |
| Device Name: | Compass Cast And MAP |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | CENTURION MEDICAL PRODUCTS CORPORATION 100 CENTURION WAY Williamston, MI 48895 |
| Contact | Matthew K. Price |
| Correspondent | Matthew K. Price CENTURION MEDICAL PRODUCTS CORPORATION 100 CENTURION WAY Williamston, MI 48895 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2016-11-22 |
| Summary: | summary |