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FDA 510(k) Application Details - K133833
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K133833
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
PHILIPS ULTRASOUND, INC.
1394 25TH STREET NW
BUFFALO, MN 55313 US
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Contact
MARK JOB
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Regulation Number
892.1550
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Classification Product Code
IYN
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More FDA Info for this Product Code
Date Received
12/17/2013
Decision Date
01/17/2014
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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