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
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Regulation Number 892.1560

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Classification Product Code IYO
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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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