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510(k) K041558

STOCKERTIR PURGE CONTROL (APC) SYSTEM by Stockert Instrumente GmbH — Product Code DTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2004
Date Received
June 10, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
Review Panel
CV
Submission Type

Other clearances by Stockert Instrumente GmbH

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  • K032213 — STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP (August 29, 2003)
  • K023622 — STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 (November 21, 2002)
  • K022280 — STOCKERT CORONARY PERFUSION CANNULAE (October 11, 2002)
  • K022321 — STOCKERT V172-28 VENOUS FEMORAL CANNULA (October 9, 2002)
  • K020571 — STOCKERT CENTRIFUGAL PUMP CONSOLE (September 23, 2002)
  • K011838 — CENTRIFUGAL PUMP (February 5, 2002)
  • K011088 — SIII ALARM AMPLIFIER (May 2, 2001)

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  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K915337 — CAPIOX LEVEL ALARM (February 21, 1992)
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  • K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (May 9, 1990)
  • K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (September 30, 1987)
  • K860076 — GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (May 30, 1986)