510(k) K894515
K894515 is an FDA 510(k) premarket notification submitted by Medical Consultants Intl. , Ltd. for the device "LISS CRANIAL STIMULATOR MODEL SBL201-M". The FDA issued a decision of Substantially Equivalent on May 3, 1990. The device falls under product code QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety), a Class II device regulated under 21 CFR 882.5800. Medical Consultants Intl. , Ltd. has at least 5 other 510(k) clearances on record.
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