Clearance Summary
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 received FDA 510(k) clearance under submission number K900246, sponsored by Ppg Industries, 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 1990-07-03.
- Submission: K900246
- Applicant / Sponsor: Ppg Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1990-07-03
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.