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FDA 510(k) Application Details - K150580
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K150580
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
WINPROBE CORPORATION
11770 US HIGHWAY 1, SUITE 405E
PALM BEACH GRADENS, FL 33408 US
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Contact
ROSE MALCHOW
Other 510(k) Applications for this Contact
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
03/09/2015
Decision Date
04/07/2015
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
Y
Expedited Review
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