Cleared Traditional

AIR SAFETY HEPA AND NON-HEPA FILTERS

K033008 · Air Safety, Ltd. · General Hospital
May 2004
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K033008 is an FDA 510(k) clearance for the AIR SAFETY HEPA AND NON-HEPA FILTERS, 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 May 13, 2004, 230 days after receiving the submission on September 26, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K033008 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2003
Decision Date May 13, 2004
Days to Decision 230 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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