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510(k) K873920

Device
BR-2 BIOREST
Applicant
BIOREST, INC.
510(k) number
K873920
Product code
JXK  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1987-12-29
Date received
1987-09-25
Regulation
882.5800
Classification name
Cranial Electrotherapy Stimulator To Treat Depression
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WM. A MENZ
Address
P.O. Box 171226 San Antonio TX US 78217 78217

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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