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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K981576
Device Name MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
Applicant
Hewlett-Packard GmbH
Schickardstrabe 4
Boeblingen, Baden-Wttbg,  DE D-71034
Applicant Contact EGON PFEIL
Correspondent
Hewlett-Packard GmbH
Schickardstrabe 4
Boeblingen, Baden-Wttbg,  DE D-71034
Correspondent Contact EGON PFEIL
Regulation Number870.1025
Classification Product Code
MHX  
Date Received05/04/1998
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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