Clearance Summary
SMDIE DEVICE INTERFACING SYSTEM received FDA 510(k) clearance under submission number K061590, sponsored by Siemens Medical Solutions Health Services Corporat. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-06-21.
- Submission: K061590
- Applicant / Sponsor: Siemens Medical Solutions Health Services Corporat
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2006-06-21
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.