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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 K912890
Device Name MODEL SONICAID AXIS
Applicant
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Applicant Contact CHARLES HOLZ
Correspondent
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Correspondent Contact CHARLES HOLZ
Regulation Number884.2740
Classification Product Code
HGM  
Date Received07/01/1991
Decision Date 01/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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