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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 K850449
Device Name DIGITAL PULSE METER HRM-100E & ETC.
Applicant
Sanyo Electric, Inc.
Household Applicance Division
323 Hojo, Kasai City
Hyogo, Japan,  JP
Applicant Contact YOSHITAKA WAKEBE
Correspondent
Sanyo Electric, Inc.
Household Applicance Division
323 Hojo, Kasai City
Hyogo, Japan,  JP
Correspondent Contact YOSHITAKA WAKEBE
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/05/1985
Decision Date 12/04/1986
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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