Clearance Summary
HI-LO FLOOR STANDING EXAM. LIGHT received FDA 510(k) clearance under submission number K842135, sponsored by Good-Lite Co.. 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 1984-07-06.
- Submission: K842135
- Applicant / Sponsor: Good-Lite Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6320
- Decision date: 1984-07-06
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.