Cleared Traditional

AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER

K132679 · Galemed Corp. · General Hospital
Apr 2014
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K132679 is an FDA 510(k) clearance for the AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Galemed Corp. (Temecula, US). The FDA issued a Cleared decision on April 18, 2014, 233 days after receiving the submission on August 28, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K132679 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2013
Decision Date April 18, 2014
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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