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FDA 510(k) Application Details - K041947
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K041947
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
INNOVATIVE IMAGING, INC.
9940 BUSINESS PARK DR.
SUITE 155
SACRAMENTO, CA 95827 US
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Contact
CYNTHIA KENDALL
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
IYO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/20/2004
Decision Date
08/16/2004
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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