Cleared Traditional

Besmed Reusable Jet Nebulizer

K150591 · Besmed Health Business Corp · Anesthesiology
Jun 2015
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K150591 is an FDA 510(k) clearance for the Besmed Reusable Jet Nebulizer, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on June 30, 2015, 113 days after receiving the submission on March 9, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K150591 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date June 30, 2015
Days to Decision 113 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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