510(k) K771534
K771534 is an FDA 510(k) premarket notification submitted by Biotronics Corp. for the device "BIOTRON 18". The FDA issued a decision of Substantially Equivalent on August 26, 1977. 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. Biotronics Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1977
- Date Received
- August 10, 1977
- 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