Cleared Traditional

BESMED JET NEBULIZER BOTTLE SET

K091272 · Besmed Health Business Corp · Anesthesiology
Nov 2009
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K091272 is an FDA 510(k) clearance for the BESMED JET NEBULIZER BOTTLE SET, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Besmed Health Business Corp (Hsin Chu City, TW). The FDA issued a Cleared decision on November 10, 2009, 194 days after receiving the submission on April 30, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K091272 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2009
Decision Date November 10, 2009
Days to Decision 194 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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