Clearance Summary
ECG ELECTRODE SYSTEM received FDA 510(k) clearance under submission number K873442, sponsored by Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-11-23.
- Submission: K873442
- Applicant / Sponsor: Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1987-11-23
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.