Clearance Summary
B & L ELECTRODE received FDA 510(k) clearance under submission number K952655, sponsored by B & L Engineering. 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 1995-09-28.
- Submission: K952655
- Applicant / Sponsor: B & L Engineering
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 1995-09-28
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.