510(k) K210570
- Device
- TraumaGuard Intra-abdominal Pressure Sensing System
- Applicant
- Sentinel Medical Technologies, LLC
- 510(k) number
- K210570
- Product code
- PHU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-29
- Date received
- 2021-02-26
- Regulation
- 510(k) Premarket Notification
- Classification name
- Intra-abdominal Pressure Monitoring Device
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Robert Mueller
- Address
- 50 N Laura St. Suite 2500 Jacksonville FL US 32202 32202
FDA Registration Numbers#
- 3003537036
- 9611590
- 3027553380
- 3008959444
- 3015337348
- 3021468326
- 3006082230
- 1018233
- 3020978007
- 3011707784
- 3014637079
- 3011383638
Source Documents#
Other 510(k) Records For Product Code PHU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070201 | BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 | C.R. Bard, Inc. | 2007-08-01 |
Legacy Summary#
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FDA Review#
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