Clearance Summary
APPLICARD (EKG) received FDA 510(k) clearance under submission number K900459, sponsored by Medi-Globe Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-07-31.
- Submission: K900459
- Applicant / Sponsor: Medi-Globe Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4330
- Decision date: 1990-07-31
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.