Clearance Summary
ISOLATED VOLTAGE/FREQUENCY CONVERTER received FDA 510(k) clearance under submission number K812619, sponsored by Bio-Feedback Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1981-10-08.
- Submission: K812619
- Applicant / Sponsor: Bio-Feedback Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1981-10-08
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.