Clearance Summary
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS received FDA 510(k) clearance under submission number K900512, sponsored by Pacesetter Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-06-25.
- Submission: K900512
- Applicant / Sponsor: Pacesetter Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3620
- Decision date: 1990-06-25
Classification & Regulation
This clearance is catalogued under FDA product code DTD and 21 CFR 870.3620, within the Cardiovascular review panel as a Class II device.