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FDA 510(k)

AG100s

K-Number: K221477 · 2022-12-29

ApplicantHospitech Respiration , Ltd.
Decision Date2022-12-29
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AG100s is a medical device manufactured by Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2022-12-29 under approval number K221477. 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 AG100s?

AG100s is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Hospitech Respiration , Ltd.. The 510(k) number is K221477.

When was AG100s approved by the FDA?

AG100s received FDA 510(k) clearance on 2022-12-29, under approval number K221477.

What company makes AG100s?

AG100s is manufactured by Hospitech Respiration , Ltd..

What is the FDA product code for AG100s?

The FDA product code for AG100s is BSK.

Other Devices by Hospitech Respiration , Ltd.

K150157AnapnoGuard 100 Respiratory Guard System K180991AG 100s

Related Devices (Code: BSK)

K152778TRACOE Cuff Pressure MonitorTracoe Medical GmbH K152865TRACOE smart Cuff ManagerTracoe Medical GmbH K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration , Ltd. K150893IntelliCuffHamilton Medical AG K180991AG 100sHospitech Respiration , Ltd. K173914VORTRAN Cuff Inflator (VCI)Vortran Medical Technology 1, Inc.

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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