510(k) K894515

LISS CRANIAL STIMULATOR MODEL SBL201-M by Medical Consultants Intl. , Ltd. — Product Code QJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1990
Date Received
July 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Device Class
Class II
Regulation Number
882.5800
Review Panel
NE
Submission Type

To provide electrical current to the head to treat insomnia and/or anxiety