TraumaGuard Intra-abdominal Pressure Sensing System

Intra-abdominal Pressure Monitoring Device

Sentinel Medical Technologies, LLC

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.

Pre-market Notification Details

Device IDK210570
510k NumberK210570
Device Name:TraumaGuard Intra-abdominal Pressure Sensing System
ClassificationIntra-abdominal Pressure Monitoring Device
Applicant Sentinel Medical Technologies, LLC 50 N Laura St, Suite 2500 Jacksonville,  FL  32202
ContactRobert Mueller
CorrespondentDarci Diage
TPL COnsulting 1056 Eugenia Pl, Suite B Carpinteria,  CA  93013
Product CodePHU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-26
Decision Date2021-10-29

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.