BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT

Filter, Bacterial, Breathing-circuit

SIMS PORTEX, INC.

The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Breathing Filter For Disposable Anesthesia Breathing Circuit.

Pre-market Notification Details

• Device ID: K002506
• 510k Number: K002506
• Device Name: BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431
• Contact: Timothy J Talcott
• Correspondent: Timothy J Talcott; SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-15
• Decision Date: 2000-12-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
35019517094897	K002506	000
30351688432036	K002506	000
15019315060045	K002506	000
15019315060052	K002506	000
15019315060069	K002506	000
15019315060076	K002506	000
15019315060083	K002506	000
15019315060106	K002506	000
15019315060113	K002506	000
15019315060120	K002506	000
15019315060137	K002506	000
15019315060144	K002506	000
15019315060854	K002506	000
15019315060861	K002506	000
15019315060878	K002506	000
35019517093739	K002506	000
30351688432012	K002506	000