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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name display, cathode-ray tube, medical
510(k) Number K992636
Device Name HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
Applicant
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Applicant Contact MIKE HUDON
Correspondent
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Correspondent Contact MIKE HUDON
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received08/06/1999
Decision Date 08/31/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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