Clearance Summary
LIGHT REFLECTION RHEOGRAPHY received FDA 510(k) clearance under submission number K833561, sponsored by Instru-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-01-08.
- Submission: K833561
- Applicant / Sponsor: Instru-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2780
- Decision date: 1985-01-08
Classification & Regulation
This clearance is catalogued under FDA product code JOM and 21 CFR 870.2780, within the Cardiovascular review panel as a Class II device.