Cleared Traditional

BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT

K002506 · Sims Portex, Inc. · General Hospital
Dec 2000
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K002506 is an FDA 510(k) clearance for the BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Sims Portex, Inc. (Keene, US). The FDA issued a Cleared decision on December 14, 2000, 121 days after receiving the submission on August 15, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K002506 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2000
Decision Date December 14, 2000
Days to Decision 121 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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