Device Classification Name
|
STIMULATOR, CRANIAL ELECTROTHERAPY
|
Regulation Number
|
882.5800
|
510(k) Number
|
K903014
|
Device Name
|
ALPHA-STIM CS
|
Applicant
|
ELECTROMEDICAL PRODUCTS, INC.
|
12591 CRENSHAW BLVD
|
HAWTHORNE, CA 90250
|
|
Contact
|
DANIEL KIRSCH
|
Product Code
|
JXK
|
Date Received
|
07/10/1990
|
Decision Date
|
05/12/1992
|
Decision
|
SUBSTANTIALLY EQUIVALENT (SE)
|
Classification Advisory Committee
|
Neurology
|
Review Advisory Committee
|
Neurology
|
Statement/Summary/Purged Status
|
Purged, no summary or statement
|
Type
|
Traditional
|
Reviewed by Third Party
|
No
|