SONICAID MODEL MERIDIAN 800

System, Monitoring, Perinatal

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Sonicaid Model Meridian 800.

Pre-market Notification Details

Device IDK902690
510k NumberK902690
Device Name:SONICAID MODEL MERIDIAN 800
ClassificationSystem, Monitoring, Perinatal
Applicant OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
ContactMichael J Smith
CorrespondentMichael J Smith
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 Received1990-06-19
Decision Date1991-02-05

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