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510(k) K060064

STETHOFLUX by Odvi — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2006
Date Received
January 9, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

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