Cleared Traditional

WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER

K953687 · Westmed Intl. · General Hospital
Sep 1995
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K953687 is an FDA 510(k) clearance for the WESTMED PEDIATRIC 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 September 18, 1995, 42 days after receiving the submission on August 7, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K953687 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1995
Decision Date September 18, 1995
Days to Decision 42 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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