Clearance Summary
MODEL 533 PHOTOTHERAPY UNIT received FDA 510(k) clearance under submission number K810953, sponsored by Narco Air-Shields. 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 1981-04-23.
- Submission: K810953
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 1981-04-23
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.