Clearance Summary
OPUS S MODEL 4121 AND 4124 PACEMAKERS received FDA 510(k) clearance under submission number K970072, sponsored by Ela Medical, 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 1997-08-29.
- Submission: K970072
- Applicant / Sponsor: Ela Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1997-08-29
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.