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FDA 510(k) Application Details - K121422
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K121422
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 MICHELLE DR
TUSTIN, CA 92780 US
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Contact
CHARLEMAGNE CHUA
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Regulation Number
892.1560
More FDA Info for this Regulation Number
Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
05/14/2012
Decision Date
08/16/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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