Clearance Summary
FOAM ECG ELECTRODE, 2060 AND 2061 received FDA 510(k) clearance under submission number K770988, sponsored by Cardio-Dynamics Laboratories, 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 1977-06-14.
- Submission: K770988
- Applicant / Sponsor: Cardio-Dynamics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1977-06-14
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.