AG100s— 510(k) K221477

Substantially Equivalent

Hospitech Respiration , Ltd.

FDA 510(k) clearance K221477 for AG100s, Substantially Equivalent on 2022-12-29. Applicant: Hospitech Respiration , Ltd.. Device class: 2.

Clearance details

Applicant: Hospitech Respiration , Ltd.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2022-05-23
Decision date: 2022-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Hospitech Respiration , Ltd.

K180991 — AG 100s2018-10-12
K150157 — AnapnoGuard 100 Respiratory Guard System2016-02-16
K131099 — AG MASS2013-05-13
K122721 — AG GUFFILL2013-05-03
K093126 — ANAPNOGUARD ENDOTRACHEAL TUBE2010-03-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.