AG 100s— 510(k) K180991

Substantially Equivalent

Hospitech Respiration , Ltd.

FDA 510(k) clearance K180991 for AG 100s, Substantially Equivalent on 2018-10-12. 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: 2018-04-16
Decision date: 2018-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petach Tikva, IL

Download summary PDF View on FDA.gov ↗

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