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510(k) K955379

IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) by International Biophysics Corp. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1996
Date Received
November 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type

Other clearances by International Biophysics Corp.

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  • K992657 — IBC VRV, MODEL 1350 (February 18, 2000)
  • K992785 — IBC FLOGUARD, MODEL 6050 (January 14, 2000)
  • K992964 — IBC VENT VALVE, MODEL 1400 (November 19, 1999)
  • K983272 — IBC FLOPUMP, MODEL 6000 (March 24, 1999)
  • K963703 — ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (April 8, 1998)
  • K963756 — IBC CARDIAC SUCTION WARD (November 14, 1997)
  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) (May 14, 1996)

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