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FDA 510(k) Application Details - K951999
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K951999
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
NEOVISION CORP.
1700 WESTLAKE AVE., NORTH
SUITE 100
SEATTLE, WA 98109 US
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Contact
JUDI HOFFMAN
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Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
04/28/1995
Decision Date
01/05/1996
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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