Cleared Traditional

HSINER JET NEBULIZER, MODEL HS-31100

K052811 · Hsiner Co., Ltd. · Anesthesiology
Dec 2005
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K052811 is an FDA 510(k) clearance for the HSINER JET NEBULIZER, MODEL HS-31100, 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 December 21, 2005, 78 days after receiving the submission on October 4, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K052811 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2005
Decision Date December 21, 2005
Days to Decision 78 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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