Cleared Traditional

Besmed PEEP Valve

K160112 · Besmed Health Business Corp · Anesthesiology
Apr 2016
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K160112 is an FDA 510(k) clearance for the Besmed PEEP Valve, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on April 29, 2016, 101 days after receiving the submission on January 19, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K160112 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2016
Decision Date April 29, 2016
Days to Decision 101 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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