Clearance Summary
INJECTOR, INSULIN received FDA 510(k) clearance under submission number K905062, sponsored by Sound 2000 Medical Systems, Inc.. 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 1991-03-15.
- Submission: K905062
- Applicant / Sponsor: Sound 2000 Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5430
- Decision date: 1991-03-15
Classification & Regulation
This clearance is catalogued under FDA product code KZE and 21 CFR 880.5430, within the General Hospital review panel as a Class II device.