Cleared Abbreviated

HSINER RESUSCITATOR

K053466 · Hsiner Co., Ltd. · Anesthesiology
Mar 2006
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K053466 is an FDA 510(k) clearance for the HSINER RESUSCITATOR, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on March 22, 2006, 99 days after receiving the submission on December 13, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K053466 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2005
Decision Date March 22, 2006
Days to Decision 99 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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