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510(k) K892941

CCO SYSTEM MODEL SP1467,SP5567,SP6267 by Spectramed, Inc. — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1989
Date Received
April 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

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