Medical Device Manufacturer · US , Austin , TX

International Biophysics Corp. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1996

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - International Biophysics Corp. Cardiovascular ✕

9 devices

1-9 of 9

Cleared Feb 18, 2000

IBC VRV, MODEL 1350

Cardiovascular · 193d

Cleared Jan 14, 2000

IBC FLOGUARD, MODEL 6050

Cardiovascular · 148d

Cleared Nov 19, 1999

IBC VENT VALVE, MODEL 1400

Cardiovascular · 78d

Cleared Mar 24, 1999

IBC FLOPUMP, MODEL 6000

Cardiovascular · 188d

Cleared Apr 08, 1998

ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)

Cardiovascular · 569d

Cleared Nov 14, 1997

IBC CARDIAC SUCTION WARD

Cardiovascular · 423d

Cleared Mar 20, 1997

CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4

Cardiovascular · 185d

Cleared May 14, 1996

IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)

Cardiovascular · 172d

Cleared May 14, 1996

IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)

Cardiovascular · 172d