Clearance Summary
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO received FDA 510(k) clearance under submission number K840454, sponsored by Air-Shields, Inc.. 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 1984-03-23.
- Submission: K840454
- Applicant / Sponsor: Air-Shields, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 1984-03-23
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.