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FDA 510(k) Application Details - K140126
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K140126
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
ANALOGIC CORPORATION
8 CENTENNIAL DRIVE
PEABODY, MA 01960 US
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Contact
ALBERT C CEFALO
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
01/16/2014
Decision Date
03/04/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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