Clearance Summary
EBICE received FDA 510(k) clearance under submission number K945067, sponsored by Electro-Biology, 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 1995-02-09.
- Submission: K945067
- Applicant / Sponsor: Electro-Biology, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5720
- Decision date: 1995-02-09
Classification & Regulation
This clearance is catalogued under FDA product code ILO and 21 CFR 890.5720, within the Physical Medicine review panel as a Class II device.