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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 K090285
Device Name SONICAID FM820 AND FM830 ENCORE
Applicant
HUNTLEIGH HEALTHCARE LTD.
35 PORTMANMOOR RD.
CARDIFF, SOUTH WALES,  GB CF24 5HN
Applicant Contact GRAHAM BOOTH
Correspondent
HUNTLEIGH HEALTHCARE LTD.
35 PORTMANMOOR RD.
CARDIFF, SOUTH WALES,  GB CF24 5HN
Correspondent Contact GRAHAM BOOTH
Regulation Number884.2740
Classification Product Code
HGM  
Date Received02/05/2009
Decision Date 07/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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