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FDA 510(k)

TraumaGuard Intra-abdominal Pressure Sensing System

K-Number: K240057 · 2024-04-17

ApplicantSentinel Medical Technologies, LLC
Decision Date2024-04-17
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TraumaGuard Intra-abdominal Pressure Sensing System is a medical device manufactured by Sentinel Medical Technologies, LLC. It received FDA 510(k) clearance on 2024-04-17 under approval number K240057. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TraumaGuard Intra-abdominal Pressure Sensing System?

TraumaGuard Intra-abdominal Pressure Sensing System is a medical device that received FDA 510(k) clearance on 2024-04-17. It is manufactured by Sentinel Medical Technologies, LLC. The 510(k) number is K240057.

When was TraumaGuard Intra-abdominal Pressure Sensing System approved by the FDA?

TraumaGuard Intra-abdominal Pressure Sensing System received FDA 510(k) clearance on 2024-04-17, under approval number K240057.

What company makes TraumaGuard Intra-abdominal Pressure Sensing System?

TraumaGuard Intra-abdominal Pressure Sensing System is manufactured by Sentinel Medical Technologies, LLC.

What is the FDA product code for TraumaGuard Intra-abdominal Pressure Sensing System?

The FDA product code for TraumaGuard Intra-abdominal Pressure Sensing System is EZL.

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Other Devices by Sentinel Medical Technologies, LLC

K210570TraumaGuard Intra-abdominal Pressure Sensing System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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