Clearance Summary
BIO-TENS received FDA 510(k) clearance under submission number K844618, sponsored by Bio-Research Associates, 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 1985-08-21.
- Submission: K844618
- Applicant / Sponsor: Bio-Research Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1985-08-21
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.