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FDA 510(k) Application Details - K020353
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K020353
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
22010 SE 51ST ST.
ISSAQUAH, WA 98029 US
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Contact
JUDI HOFFMAN
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Regulation Number
892.1550
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Classification Product Code
IYN
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Date Received
02/04/2002
Decision Date
02/13/2002
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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