Clearance Summary
ACCU-RYNGE INSULIN PUMP #SP-250 received FDA 510(k) clearance under submission number K820482, sponsored by Delta Medical Industries. 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 1982-03-26.
- Submission: K820482
- Applicant / Sponsor: Delta Medical Industries
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1982-03-26
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.