Clearance Summary
OMNI INFANT PHOTOTHERAPY UNIT received FDA 510(k) clearance under submission number K834430, sponsored by Rocky Mountain Medical Corp.. 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 1984-04-30.
- Submission: K834430
- Applicant / Sponsor: Rocky Mountain Medical Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 1984-04-30
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.