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510(k) K992964

IBC VENT VALVE, MODEL 1400 by International Biophysics Corp. — Product Code MNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1999
Date Received
September 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Pressure Relief, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

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  • 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)
  • K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) (May 14, 1996)
  • K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) (May 14, 1996)

Other clearances for product code MNJ

  • K941492 — PRESSURE RELIEF VALVE (October 26, 1994)