Clearance Summary
BIO-STIMULATOR, MODEL 400 received FDA 510(k) clearance under submission number K813100, sponsored by Med-Western Electronics, 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 1981-11-27.
- Submission: K813100
- Applicant / Sponsor: Med-Western Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1981-11-27
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.