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510(k) K053630

LEVITRONIX CENTRIMAG PRIMARY CONSOLE by Levitronix, LLC — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2006
Date Received
December 29, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

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  • K051209 — LEVITRONIX CENTRIMAG BACK-UP CONSOLE (September 8, 2005)
  • K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (March 25, 2003)

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