Medical Device Manufacturer · US , Indianapolis , IN

Gibeck, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1990

Recent clearances: ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212), THERMAL REGULATION SYSTEM BLANKET, HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gibeck, Inc. General Hospital ✕

3 devices

1-3 of 3

Cleared Dec 02, 1997

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

General Hospital · 351d

Cleared Apr 15, 1997

HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT...

General Hospital · 162d

Cleared May 02, 1996

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

General Hospital · 195d