Clearance Summary
VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE received FDA 510(k) clearance under submission number K943521, sponsored by Schiff & 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 1995-02-14.
- Submission: K943521
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6500
- Decision date: 1995-02-14
Classification & Regulation
This clearance is catalogued under FDA product code FRA and 21 CFR 880.6500, within the General Hospital review panel as a Class II device.