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510(k) K940811

Device
BRAINTRACE
Applicant
BRAINSTORMS MONITORING CORP.
510(k) number
K940811
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-02
Date received
1994-02-22
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DIEGO L GRU
Address
1776 N. Moorpark Rd. Thousand Oaks CA US 91360 91360

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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