Cleared Traditional

AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE

K050953 · Air Safety, Ltd. · General Hospital
Jun 2005
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K050953 is an FDA 510(k) clearance for the AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Air Safety, Ltd. (Mccordsville, US). The FDA issued a Cleared decision on June 29, 2005, 75 days after receiving the submission on April 15, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K050953 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2005
Decision Date June 29, 2005
Days to Decision 75 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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