MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL 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 9000 Recording & Electrophysiological System.

Pre-market Notification Details

Device IDK860456
510k NumberK860456
Device Name:MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
ClassificationFull-montage Standard Electroencephalograph
Applicant OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
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 Received1986-02-05
Decision Date1986-08-11

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