TraumaGuard Intra-abdominal Pressure Sensing System— 510(k) K210570

Name: FDA 510(k) clearance K210570
Creator: U.S. Food and Drug Administration
Published: 2021-10-29

Substantially Equivalent

Sentinel Medical Technologies, LLC

FDA 510(k) clearance K210570 for TraumaGuard Intra-abdominal Pressure Sensing System, Substantially Equivalent on 2021-10-29. Applicant: Sentinel Medical Technologies, LLC. Device class: Unclassified.

Clearance details

Applicant: Sentinel Medical Technologies, LLC
Product code: Code PHU
Device class: Unclassified
Advisory panel: Unknown
Date received: 2021-02-26
Decision date: 2021-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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