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FDA 510(k) Application Details - K020630
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K020630
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
UltraSonix Medical Corporation
535-2660 OAK ST.
VANCOUVER, BC V6H 3Z1 CA
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Contact
KEN SETO
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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
02/26/2002
Decision Date
06/13/2002
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
N
Expedited Review
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