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FDA 510(k) Application Details - K010950
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K010950
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
ACUSON CORP.
555 13TH ST., N.W.
WASHINGTON, DC 20004-1109 US
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Contact
HOWARD M HOLSTEIN
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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
03/29/2001
Decision Date
06/27/2001
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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