510(k) K834519
K834519 is an FDA 510(k) premarket notification submitted by Thought Technology , Ltd. for the device "CALMTONE". The FDA issued a decision of Substantially Equivalent on Jan 30, 1984. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Thought Technology , Ltd. has 21 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 30, 1984
- Date Received
- Dec 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Biofeedback
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type
- 510(k) Exempt