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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K911139
Device Name HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
Applicant
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Applicant Contact RICHARD BEEBE
Correspondent
Hewlett-Packard Co.
175 Waltham St.
P.O.Box 9030
Waltham,  MA  02254
Correspondent Contact RICHARD BEEBE
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/14/1991
Decision Date 06/11/1991
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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