Clearance Summary
BIO-EMG MODEL 800 received FDA 510(k) clearance under submission number K873947, sponsored by Bio-Research Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1988-04-27.
- Submission: K873947
- Applicant / Sponsor: Bio-Research Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 1988-04-27
Classification & Regulation
This clearance is catalogued under FDA product code KZM and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.