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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 K905606
Device Name EXTERNAL FETAL MONITOR TRANSDUCER HOLDER
Applicant
Atheus Corp.
Suite 1200 Two Century Plz.
2049 Century Park E.
Los Angeles,  CA  90067
Applicant Contact MARC H BOZEMAN
Correspondent
Atheus Corp.
Suite 1200 Two Century Plz.
2049 Century Park E.
Los Angeles,  CA  90067
Correspondent Contact MARC H BOZEMAN
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/14/1990
Decision Date 03/12/1991
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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