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510(k) K093650

BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM by Medtronic, Inc. — Product Code DTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2010
Date Received
November 25, 2009
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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Other clearances for product code DTY

  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • K954501 — BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (January 16, 1996)
  • K902654 — CDI (TM) SYSTEM 100 MONITORING SYSTEM (November 5, 1990)
  • K900860 — PERFUSION MONITOR (August 14, 1990)
  • K864703 — MODIFIED GAS-STAT(TM) MONITORING SYSTEM (February 19, 1987)
  • K840749 — GAST STAT MONITORING SYSTEM (April 17, 1984)
  • K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM (December 22, 1982)