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510(k) K850541

Device
SLEEP STAGER
Applicant
OXFORD MEDILOG, INC.
510(k) number
K850541
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-02
Date received
1985-02-11
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN K LAURIE
Address
11526 53rd. St. N. Clearwater FL US 33520 33520

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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