Cleared Traditional

70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER

K091185 · Hsiner Co., Ltd. · General Hospital
Jul 2009
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K091185 is an FDA 510(k) clearance for the 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on July 24, 2009, 92 days after receiving the submission on April 23, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K091185 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2009
Decision Date July 24, 2009
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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