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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K902088
Device Name MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
Applicant
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Applicant Contact V ANDERSON
Correspondent
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Correspondent Contact V ANDERSON
Regulation Number870.2100
Classification Product Code
DPW  
Date Received05/10/1990
Decision Date 08/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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