Cleared Traditional

WESTMED BACTERIAL/VIRAL FILTER

K951484 · Westmed Intl. · General Hospital
Apr 1995
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K951484 is an FDA 510(k) clearance for the WESTMED BACTERIAL/VIRAL FILTER, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on April 24, 1995, 25 days after receiving the submission on March 30, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K951484 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1995
Decision Date April 24, 1995
Days to Decision 25 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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