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FDA 510(k)

AnapnoGuard 100 Respiratory Guard System

K-Number: K150157 · 2016-02-16

ApplicantHospitech Respiration , Ltd.
Decision Date2016-02-16
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Hospitech Respiration , Ltd.. The 510(k) number is K150157.

When was AnapnoGuard 100 Respiratory Guard System approved by the FDA?

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

What company makes AnapnoGuard 100 Respiratory Guard System?

AnapnoGuard 100 Respiratory Guard System is manufactured by Hospitech Respiration , Ltd..

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

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

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Other Devices by Hospitech Respiration , Ltd.

K180991AG 100s K221477AG100s

Related Devices (Code: BSK)

K152778TRACOE Cuff Pressure MonitorTracoe Medical GmbH K152865TRACOE smart Cuff ManagerTracoe Medical GmbH K150893IntelliCuffHamilton Medical AG K180991AG 100sHospitech Respiration , Ltd. K173914VORTRAN Cuff Inflator (VCI)Vortran Medical Technology 1, Inc. K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.

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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