510(k) K894515
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