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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 K944262
Device Name ECG MONITOR
Applicant
Fukuda Denshi USA, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALF
Correspondent
Fukuda Denshi USA, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALF
Regulation Number870.2300
Classification Product Code
DRT  
Date Received08/30/1994
Decision Date 05/12/1995
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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