Clearance Summary
PULSTRON MODEL 100 received FDA 510(k) clearance under submission number K781835, sponsored by Micro-Rel. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1978-12-21.
- Submission: K781835
- Applicant / Sponsor: Micro-Rel
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1978-12-21
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.