Cleared Traditional

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]

K121382 · Westmed, Inc. · General Hospital
Dec 2012
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K121382 is an FDA 510(k) clearance for the WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)], a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Westmed, Inc. (Tucson, US). The FDA issued a Cleared decision on December 6, 2012, 212 days after receiving the submission on May 8, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K121382 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2012
Decision Date December 06, 2012
Days to Decision 212 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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