Clearance Summary
BASIC LIGHT received FDA 510(k) clearance under submission number K861289, sponsored by Burton Medical Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1986-04-18.
- Submission: K861289
- Applicant / Sponsor: Burton Medical Products Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6320
- Decision date: 1986-04-18
Classification & Regulation
This clearance is catalogued under FDA product code KZF and 21 CFR 880.6320, within the General Hospital review panel as a Class I device.