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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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