Clearance Summary
CALMTONE received FDA 510(k) clearance under submission number K834519, sponsored by Thought Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-01-30.
- Submission: K834519
- Applicant / Sponsor: Thought Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1984-01-30
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.