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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K871385
Device Name MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
Applicant
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Applicant Contact DONALD ANDRESEN
Correspondent
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Correspondent Contact DONALD ANDRESEN
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/07/1987
Decision Date 05/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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