Medical Device Manufacturer · US , Indianapolis , IN

Gibeck, Inc.

15 submissions · 15 cleared · Since 1990
15
Total
15
Cleared
0
Denied

Gibeck, Inc. — FDA 510(k) Submissions

Gibeck, Inc. has submitted 15 FDA 510(k) premarket notifications since 1990, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Condenser, Heat And Moisture (artificial Nose), Filter, Bacterial, Breathing-circuit, System, Thermal Regulating, Absorbent, Carbon-dioxide, Analyzer, Gas, Carbon-dioxide, Gaseous-phase . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K965016 · CAH Filter, Bacterial,... · General Hospital
Dec 1997 351d
THERMAL REGULATION SYSTEM BLANKET
K964377 · DWJ System, Thermal Regulating · Cardiovascular
Apr 1997 173d
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
K964382 · CAH Filter, Bacterial,... · General Hospital
Apr 1997 162d
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
K960511 · DWJ System, Thermal Regulating · Cardiovascular
Jan 1997 343d
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K954828 · CAH Filter, Bacterial,... · General Hospital
May 1996 195d
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
K953491 · BYD Condenser, Heat And... · Anesthesiology
Aug 1995 31d
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
K953544 · BYD Condenser, Heat And... · Anesthesiology
Aug 1995 28d
HUMID-VENT TRACH-VENT
K952845 · BYD Condenser, Heat And... · Anesthesiology
Jul 1995 34d
HUMID-VENT 1
K952750 · BYD Condenser, Heat And... · Anesthesiology
Jul 1995 35d
HUMID-VENT 2
K952844 · BYD Condenser, Heat And... · Anesthesiology
Jul 1995 29d
HUMID-VENT FILTER PEDI
K952084 · BYD Condenser, Heat And... · Anesthesiology
Jun 1995 40d
HUMID-VENT MICRO
K951856 · BYD Condenser, Heat And... · Anesthesiology
Jun 1995 47d
XENON CIRCUIT
K914747 · IYT System, Rebreathing,... · Radiology
Feb 1992 128d
GAS SAMPLING NASAL CANNULA
K900979 · CCK Analyzer, Gas,... · Anesthesiology
Mar 1990 14d
DISPOSABLE CO2 ABSORBER/E
K897171 · CBL Absorbent, Carbon-dioxide · Anesthesiology
Mar 1990 75d
Filters