Clearance Summary
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES received FDA 510(k) clearance under submission number K971444, sponsored by 3M Medical Products Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-06-11.
- Submission: K971444
- Applicant / Sponsor: 3M Medical Products Group
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1997-06-11
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.