Clearance Summary
M444 EMG MONITOR received FDA 510(k) clearance under submission number K880916, sponsored by Bio-Logic Devices. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-05-11.
- Submission: K880916
- Applicant / Sponsor: Bio-Logic Devices
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1988-05-11
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.