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510(k) K963698

CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 by International Biophysics Corp. — Product Code DTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1997
Date Received
September 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4410
Review Panel
CV
Submission Type

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  • K840749 — GAST STAT MONITORING SYSTEM (April 17, 1984)
  • K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM (December 22, 1982)