BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA

Filter, Bacterial, Breathing-circuit

VITAL SIGNS, INC.

The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Bacterial/viral Filter Product Numbers 5100filt, 5100thinm, 5100hepa.

Pre-market Notification Details

• Device ID: K951047
• 510k Number: K951047
• Device Name: BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Contact: Steve Lieberman
• Correspondent: Steve Lieberman; VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-06
• Decision Date: 1995-06-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30889483614895	K951047	000
30889483586963	K951047	000
30889483586956	K951047	000
30889483586901	K951047	000
30889483584853	K951047	000
30889483584846	K951047	000
30889483580695	K951047	000