Clearance Summary
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE received FDA 510(k) clearance under submission number K002414, sponsored by Fisher & Paykel Healthcare, Ltd.. 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 2000-09-25.
- Submission: K002414
- Applicant / Sponsor: Fisher & Paykel Healthcare, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 2000-09-25
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.