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510(k) K910616

Device
LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR
Applicant
LIFE BALANCE INTL., INC.
510(k) number
K910616
Product code
JXK  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-12
Date received
1991-02-12
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
KELLY D GROVER
Address
13100 S. 300 East Draper UT US 84020 84020

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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