Clearance Summary
MODEL M402 EMG MONITOR received FDA 510(k) clearance under submission number K864660, sponsored by Bio-Logic Devices. 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 1987-02-04.
- Submission: K864660
- Applicant / Sponsor: Bio-Logic Devices
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 1987-02-04
Classification & Regulation
This clearance is catalogued under FDA product code IKN and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.