SLEEP STAGER

Non-normalizing Quantitative Electroencephalograph Software

OXFORD MEDILOG, INC.

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

Pre-market Notification Details

Device IDK850541
510k NumberK850541
Device Name:SLEEP STAGER
ClassificationNon-normalizing Quantitative Electroencephalograph Software
Applicant OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
ContactJohn K Laurie
CorrespondentJohn K Laurie
OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater,  FL  33520
Product CodeOLT  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-11
Decision Date1985-08-02

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