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FDA 510(k) Application Details - K081661
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K081661
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
PHILIPS ULTRASOUND, INC.
22100 BOTHELL EVERETT HWY.
BOTHELL, WA 98021 US
Other 510(k) Applications for this Company
Regulation Number
892.1550
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Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/13/2008
Decision Date
06/24/2008
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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