FDA 510(k)

AG 100s

K-Number: K180991 · 2018-10-12

Decision Date2018-10-12

Product CodeBSK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AG 100s 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 2018-10-12 under 510(k) number K180991. 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 AG 100s?

AG 100s is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K180991.

When did AG 100s receive FDA 510(k) clearance?

AG 100s received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180991.

Who is the listed applicant for AG 100s?

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 AG 100s?

The FDA product code for AG 100s is BSK.

Other records listing Hospitech Respiration , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221477AG100s K150157AnapnoGuard 100 Respiratory Guard System

Related Devices (Code: BSK)

K261499TrachFlushAw Technologies Aps K243562CuffGuardIdmed K242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies Aps K221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.