Clearance Summary
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) received FDA 510(k) clearance under submission number K952363, sponsored by Ela Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-08-15.
- Submission: K952363
- Applicant / Sponsor: Ela Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1995-08-15
Classification & Regulation
This clearance is catalogued under FDA product code ELA and 21 CFR 872.4565, within the Dental review panel as a Class I device.