FDA 510(k)

创伤卫士腹腔压力感应系统

K号: K240057 · 2024-04-17

决定日期2024-04-17

产品代码EZL

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Sentinel Medical Technologies, LLC. The 510(k) number is K240057.

When did TraumaGuard Intra-abdominal Pressure Sensing System receive FDA 510(k) clearance?

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

Who is the listed applicant for TraumaGuard Intra-abdominal Pressure Sensing System?

The FDA 510(k) record lists Sentinel Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

列明Sentinel Medical Technologies, LLC为申报人的其他记录

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K210570创伤卫士腹腔压力感应系统

官方来源

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