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510(k) K210570

TraumaGuard Intra-abdominal Pressure Sensing System by Sentinel Medical Technologies, LLC — Product Code PHU

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.

Other clearances by Sentinel Medical Technologies, LLC

  • K240057 — TraumaGuard Intra-abdominal Pressure Sensing System (April 17, 2024)

Other clearances for product code PHU

  • K070201 — BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 (August 1, 2007)