Clearance Summary
PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 received FDA 510(k) clearance under submission number K040853, sponsored by International Hospital Supply 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 2004-06-21.
- Submission: K040853
- Applicant / Sponsor: International Hospital Supply Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 2004-06-21
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.