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FDA 510(k) Application Details - K022153
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K022153
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
DIAGNOSTIC ULTRASOUND CORP.
21222 30TH DRIVE SE, STE. 120
BOTHELL, WA 98021 US
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Contact
RUSS GARRISON
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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
07/02/2002
Decision Date
08/15/2002
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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