The following data is part of a premarket notification filed by Sentinel Medical Technologies, Llc with the FDA for Traumaguard Intra-abdominal Pressure Sensing System.
| Device ID | K210570 |
| 510k Number | K210570 |
| Device Name: | TraumaGuard Intra-abdominal Pressure Sensing System |
| Classification | Intra-abdominal Pressure Monitoring Device |
| Applicant | Sentinel Medical Technologies, LLC 50 N Laura St, Suite 2500 Jacksonville, FL 32202 |
| Contact | Robert Mueller |
| Correspondent | Darci Diage TPL COnsulting 1056 Eugenia Pl, Suite B Carpinteria, CA 93013 |
| Product Code | PHU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-10-29 |