Clearance Summary
GEM-6, WITH COMPONENTS received FDA 510(k) clearance under submission number K854357, sponsored by Diamond Electro-Tech, 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 1986-01-08.
- Submission: K854357
- Applicant / Sponsor: Diamond Electro-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4330
- Decision date: 1986-01-08
Classification & Regulation
This clearance is catalogued under FDA product code DRY and 21 CFR 870.4330, within the Cardiovascular review panel as a Class II device.