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FDA 510(k) Application Details - K961459
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K961459
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041-3003 US
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Contact
TERRANCE J SWEENEY
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
IYO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/16/1996
Decision Date
03/26/1997
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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