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510(k) K883812

Device
HP-1 (HEALTHPAX)
Applicant
HEALTHDIRECTIONS, INC.
510(k) number
K883812
Product code
JXK  
Decision
Substantially Equivalent (SESE)
Decision date
1988-11-28
Date received
1988-09-08
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
STECKER, PHD
Address
Post Office Box 874 Morrisville PA US 19067 19067

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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