FDA 510(k)

トラウマガード腹腔圧感知システム

K番号: K210570 · 2021-10-29

決定日2021-10-29

製品コードPHU

決定大幅同等

医療機器の概要

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 2021-10-29 under 510(k) number K210570. The device is classified under product code PHU. FDA Decision: Substantially Equivalent.

よくある質問

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 2021-10-29. The listed applicant is Sentinel Medical Technologies, LLC. The 510(k) number is K210570.

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 2021-10-29, under 510(k) number K210570.

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 PHU.

申請者としてSentinel Medical Technologies, LLCを記載するその他の記録

K240057トラウマガード腹腔圧感知システム

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医療機器の概要

よくある質問

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申請者としてSentinel Medical Technologies, LLCを記載するその他の記録

公式ソース