MODEL 5000 AMBULATORY MONITORING SYSTEM

Full-montage Standard Electroencephalograph

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model 5000 Ambulatory Monitoring System.

Pre-market Notification Details

Device IDK871500
510k NumberK871500
Device Name:MODEL 5000 AMBULATORY MONITORING SYSTEM
ClassificationFull-montage Standard 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 CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-16
Decision Date1987-07-01

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