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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K941811
Device Name HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
Applicant
Hewlett-Packard Co.
175 Wyman St.
Waltham,  MA  02451 -1223
Applicant Contact RAY STELTING
Correspondent
Hewlett-Packard Co.
175 Wyman St.
Waltham,  MA  02451 -1223
Correspondent Contact RAY STELTING
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/12/1994
Decision Date 05/17/1994
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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