510(k) K210570
K210570 is an FDA 510(k) premarket notification submitted by Sentinel Medical Technologies, LLC for the device "TraumaGuard Intra-abdominal Pressure Sensing System". The FDA issued a decision of Substantially Equivalent on October 29, 2021. The device falls under product code PHU (Intra-Abdominal Pressure Monitoring Device), a Class U device. Sentinel Medical Technologies, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2021
- Date Received
- February 26, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intra-Abdominal Pressure Monitoring Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.