FDA 510(k) Application Details - K972348

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K972348
Device Name Transducer, Ultrasonic, Diagnostic
Applicant HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1087 US
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Contact ROB BUTLER
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 06/24/1997
Decision Date 07/24/1997
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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