FDA 510(k) Application Details - K980687

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K980687
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1085 US
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Contact PAUL SCHRADER
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 02/23/1998
Decision Date 05/22/1998
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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