Cleared Special

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS

K082009 · Hsiner Co., Ltd. · Anesthesiology
Aug 2008
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K082009 is an FDA 510(k) clearance for the HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on August 22, 2008, 30 days after receiving the submission on July 23, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K082009 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2008
Decision Date August 22, 2008
Days to Decision 30 days
Submission Type Special
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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