Clearance Summary
INFANT PHOTOTHERAPY MASK received FDA 510(k) clearance under submission number K851918, sponsored by Alba Health Care. 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 1985-06-07.
- Submission: K851918
- Applicant / Sponsor: Alba Health Care
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5270
- Decision date: 1985-06-07
Classification & Regulation
This clearance is catalogued under FDA product code FOK and 21 CFR 880.5270, within the General Hospital review panel as a Class I device.