Clearance Summary
DAISCOPE & ACCESSORIES received FDA 510(k) clearance under submission number K790506, sponsored by Simonsen & Weels Eftf.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-04-09.
- Submission: K790506
- Applicant / Sponsor: Simonsen & Weels Eftf.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1979-04-09
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.