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FDA 510(k) Application Details - K955942
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K955942
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
DIAGNOSTIC ULTRASOUND CORP.
18109 NE 76TH ST.
REDMOND, WA 98052 US
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Contact
GERALD MCMORROW
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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
12/26/1995
Decision Date
03/15/1996
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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