Clearance Summary
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 received FDA 510(k) clearance under submission number K884983, sponsored by S & W Medico Teknik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-03-09.
- Submission: K884983
- Applicant / Sponsor: S & W Medico Teknik
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1989-03-09
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.