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FDA 510(k) Application Details - K090214
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K090214
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
VERATHON INCORPORATED
20001 NORTH CREEK PKWY
BOTHEL, WA 98011 US
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Contact
KRISTIAN NIELSEN
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Regulation Number
892.1560
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Classification Product Code
IYO
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Date Received
01/29/2009
Decision Date
03/13/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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