Cleared Traditional

WESTMED CONDESATE COLLECTION TRAP

K954271 · Westmed Intl. · Anesthesiology
Dec 1995
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K954271 is an FDA 510(k) clearance for the WESTMED CONDESATE COLLECTION TRAP, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on December 28, 1995, 107 days after receiving the submission on September 12, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K954271 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1995
Decision Date December 28, 1995
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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