MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog 9200 Eeg Replay/analysis System.

Pre-market Notification Details

Device IDK891383
510k NumberK891383
Device Name:MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
ClassificationAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
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 CodeOLZ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-09
Decision Date1989-06-01

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