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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 K922058
Device Name MODELS M1175A AND M1176A COMPONENT MONITORING SYST
Applicant
Hewlett-Packard Co.
Schuckardstrabe 4
7030 Boblingen
Germany,  DE
Applicant Contact GERHARD LENKE
Correspondent
Hewlett-Packard Co.
Schuckardstrabe 4
7030 Boblingen
Germany,  DE
Correspondent Contact GERHARD LENKE
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/22/1992
Decision Date 10/06/1992
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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