Clearance Summary
MODEL SR-1020LF received FDA 510(k) clearance under submission number K821032, sponsored by Stewart-Riess Labs. 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 1982-05-03.
- Submission: K821032
- Applicant / Sponsor: Stewart-Riess Labs
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1982-05-03
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.