Clearance Summary
PULSE GENERATOR MODEL 208 received FDA 510(k) clearance under submission number K781178, sponsored by Elema-Schonander, 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 1978-09-07.
- Submission: K781178
- Applicant / Sponsor: Elema-Schonander, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1978-09-07
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.