EXHALATION VALVE— 510(k) K132143

Substantially Equivalent

Intersurgical Incorporated

FDA 510(k) clearance K132143 for EXHALATION VALVE, Substantially Equivalent on 2014-06-04. Applicant: Intersurgical Incorporated. Device class: 2.

Clearance details

Applicant: Intersurgical Incorporated
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2013-07-11
Decision date: 2014-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, US

Download summary PDF View on FDA.gov ↗

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