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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, body composition
510(k) Number K994242
Device Name BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
Applicant
BODYSTAT LTD.
PO BOX 50
DOUGLAS ISLE OF MAN
BRITISH ISLES,  BR IM99 1DQ
Applicant Contact I. J MEEUWSEN
Correspondent
BODYSTAT LTD.
PO BOX 50
DOUGLAS ISLE OF MAN
BRITISH ISLES,  BR IM99 1DQ
Correspondent Contact I. J MEEUWSEN
Regulation Number870.2770
Classification Product Code
MNW  
Date Received12/16/1999
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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