MODEL SONICAID AXIS

System, Monitoring, Perinatal

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model Sonicaid Axis.

Pre-market Notification Details

Device IDK912890
510k NumberK912890
Device Name:MODEL SONICAID AXIS
ClassificationSystem, Monitoring, Perinatal
Applicant OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
ContactCharles Holz
CorrespondentCharles Holz
OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-01
Decision Date1992-01-09

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