ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT

Filter, Bacterial, Breathing-circuit

GIBECK, INC.

The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Iso-gard Hepa Filter-hme, Iso-ard Hepa Filter-hme W/port.

Pre-market Notification Details

• Device ID: K954828
• 510k Number: K954828
• Device Name: ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236
• Contact: Brian Grigsby
• Correspondent: Brian Grigsby; GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-10-20
• Decision Date: 1996-05-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
44026704389061	K954828	000
24026704348125	K954828	000
24026704348095	K954828	000
24026704348088	K954828	000
44026704348075	K954828	000