Clearance Summary
BIO-SENSOR 01 EKG ELECTRODE received FDA 510(k) clearance under submission number K911472, sponsored by Bio-Sensor, 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 1991-10-10.
- Submission: K911472
- Applicant / Sponsor: Bio-Sensor, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1991-10-10
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.