ANAPNOGUARD ENDOTRACHEAL TUBE— 510(k) K093126

Name: FDA 510(k) clearance K093126
Creator: U.S. Food and Drug Administration
Published: 2010-03-02

Substantially Equivalent

Hospitech Respiration , Ltd.

FDA 510(k) clearance K093126 for ANAPNOGUARD ENDOTRACHEAL TUBE, Substantially Equivalent on 2010-03-02. Applicant: Hospitech Respiration , Ltd.. Device class: 1.

Clearance details

Applicant: Hospitech Respiration , Ltd.
Product code: Code BTP
Device class: Class 1
Regulation: 21 CFR 868.5420
Advisory panel: Anesthesiology
Date received: 2009-10-02
Decision date: 2010-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

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