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510(k) K022004

CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 by Biosensors International-USA — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2003
Date Received
June 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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