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510(k) K001388

DATA MASTER PERFUSION MONITORING SYSTEM by Dideco — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2000
Date Received
May 2, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type

Other clearances by Dideco

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  • K051232 — D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDI (May 20, 2005)
  • K050890 — ECC.O SYSTEM (May 5, 2005)
  • K050447 — PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (March 8, 2005)
  • K043323 — D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RE (February 1, 2005)
  • K041061 — D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS (May 6, 2004)
  • K033323 — D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HO (January 13, 2004)
  • K033987 — D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS (January 8, 2004)
  • K033714 — MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COAT (December 11, 2003)
  • K032040 — IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, (July 9, 2003)

Other clearances for product code DRY

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  • K202154 — B-Capta (April 1, 2021)
  • K202557 — Quantum Workstation 12 Elite (October 2, 2020)
  • K182110 — CDI Blood Parameter Monitoring System 550 (November 2, 2018)
  • K181923 — Quantum Workstation 12.1 (August 17, 2018)
  • K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (March 28, 2018)
  • K163657 — Quantum Workstation (January 18, 2017)
  • K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURF (October 23, 2014)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)