Clearance Summary
FUKUDA DENSHI received FDA 510(k) clearance under submission number K103134, sponsored by Fukuda Denshi USA, 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 2011-03-11.
- Submission: K103134
- Applicant / Sponsor: Fukuda Denshi USA, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2011-03-11
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.