International Biophysics Corporation Afflovest

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K122480 ↗

FDA Product Code

BYI

FDA applicant

International Biophysics Corporation

Device Class

Class II

Regulation

21 CFR Part 868.5665

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• IBC Vent Valve, Model 1400

  Class II

  FDA 510(k) K992964 Active Cleared 19 Nov 1999

• Ibc Vrv, Model 1350

  Class II

  FDA 510(k) K992657 Active Cleared 18 Feb 2000

• CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4

  Class II

  FDA 510(k) K963698 Active Cleared 20 Mar 1997

• Ibc Floguard, Model 6050

  Class II

  FDA 510(k) K992785 Active Cleared 14 Jan 2000

• Ibc Cardiac Suction Ward

  Class II

  FDA 510(k) K963756 Active Cleared 14 Nov 1997

• Accuflo Monitoring System (1800)/ Accuflo Probe (8000)

  Class II

  FDA 510(k) K963703 Active Cleared 8 Apr 1998

See all devices from International Biophysics Corp. →