Cleared Traditional

WESTMED CIRCULARIE PEP DEVICES

K955047 · Westmed Intl. · Anesthesiology
Mar 1996
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K955047 is an FDA 510(k) clearance for the WESTMED CIRCULARIE PEP DEVICES, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on March 27, 1996, 145 days after receiving the submission on November 3, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K955047 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1995
Decision Date March 27, 1996
Days to Decision 145 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BYE — Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5965

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