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510(k) K002118

STOCKERT COMPACT SYSTEM VERSION 2.0 by Stoeckert Instrumente — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2000
Date Received
July 13, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type

Other clearances by Stoeckert Instrumente

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  • K992635 — INTERFACE MODULE IDDD (December 20, 1999)
  • K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (November 23, 1999)
  • K982014 — STOCKERT COMPACT SYSTEM (September 4, 1998)
  • K972321 — S3 MAST PUMP (February 27, 1998)
  • K971520 — S3 CYCLIC RPM CONTROL (September 10, 1997)
  • K962320 — S3 CARDIOPLEGIA CONTROL (January 10, 1997)
  • K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (February 22, 1996)
  • K955038 — STOCKERT S3 DOUBLE HEAD PUMP MODULE (February 21, 1996)

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