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FDA 510(k) Application Details - K102997
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K102997
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
UltraSonix Medical Corporation
130-4311 VIKING WAY
RICHMOND, BRITISH COLUMBIA V6V 2K9 CA
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Contact
CHAS YU
Other 510(k) Applications for this Contact
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
10/07/2010
Decision Date
12/21/2010
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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