MEDILOG VISION

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

OXFORD INSTRUMENTS, PLC.

The following data is part of a premarket notification filed by Oxford Instruments, Plc. with the FDA for Medilog Vision.

Pre-market Notification Details

Device IDK961636
510k NumberK961636
Device Name:MEDILOG VISION
ClassificationAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater,  FL  34620
ContactCharles Holz
CorrespondentCharles Holz
OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater,  FL  34620
Product CodeOLZ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-29
Decision Date1997-01-17

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