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510(k) K954501

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM by Medtronic Bio-Medicus, Inc. — Product Code DTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1996
Date Received
September 28, 1995
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

Other clearances by Medtronic Bio-Medicus, Inc.

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  • K941922 — MEDSAT OXYGEN SATURATION SYSTEM (February 17, 1995)
  • K936091 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER (December 23, 1994)
  • K941921 — BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 (July 20, 1994)
  • K924208 — BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) (July 8, 1993)
  • K926357 — MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 (June 2, 1993)
  • K924206 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E (May 7, 1993)
  • K924205 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 (May 6, 1993)
  • K924642 — MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER (March 26, 1993)

Other clearances for product code DTY

  • K093650 — BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM (February 17, 2010)
  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • 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)