FDA 510(k)

AnapnoGuard 100 호흡 보호 시스템

K-번호: K150157 · 2016-02-16

결정일2016-02-16

제품 코드BSK

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결정Substantially Equivalent

기기 요약

AnapnoGuard 100 Respiratory Guard System is the device name listed in this FDA 510(k) record. The listed applicant is Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K150157. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AnapnoGuard 100 Respiratory Guard System?

AnapnoGuard 100 Respiratory Guard System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K150157.

When did AnapnoGuard 100 Respiratory Guard System receive FDA 510(k) clearance?

AnapnoGuard 100 Respiratory Guard System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K150157.

Who is the listed applicant for AnapnoGuard 100 Respiratory Guard System?

The FDA 510(k) record lists Hospitech Respiration , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AnapnoGuard 100 Respiratory Guard System?

The FDA product code for AnapnoGuard 100 Respiratory Guard System is BSK.

Hospitech Respiration , Ltd.를 신청인으로 등재한 기타 기록

K221477AG100s K180991AG 100s

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