Cleared Traditional

DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

K133957 · Galemed Corp. · Anesthesiology
Apr 2014
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K133957 is an FDA 510(k) clearance for the DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Galemed Corp. (Xiamen, Fujian, CN). The FDA issued a Cleared decision on April 14, 2014, 112 days after receiving the submission on December 23, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K133957 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2013
Decision Date April 14, 2014
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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