Clearance Summary
SIEMENS-ELMA PULSE GENERATOR #718 received FDA 510(k) clearance under submission number K830344, sponsored by Burditt & Calkins-Siemens-Elema. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-05-27.
- Submission: K830344
- Applicant / Sponsor: Burditt & Calkins-Siemens-Elema
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1983-05-27
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.