Cleared Traditional

CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235

K063268 · Hsiner Co., Ltd. · Anesthesiology
Feb 2007
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K063268 is an FDA 510(k) clearance for the CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on February 23, 2007, 116 days after receiving the submission on October 30, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K063268 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2006
Decision Date February 23, 2007
Days to Decision 116 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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