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FDA 510(k) Application Details - K121689
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K121689
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
VITACON MEDICAL INC.
4020 Viking Way
Unit 130
Richmond V6V 2L4 CA
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Contact
RON EVANS
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Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
06/07/2012
Decision Date
09/19/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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