Clearance Summary
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL received FDA 510(k) clearance under submission number K852487, 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 1985-09-19.
- Submission: K852487
- Applicant / Sponsor: Fukuda Denshi USA, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1985-09-19
Classification & Regulation
This clearance is catalogued under FDA product code DSF and 21 CFR 870.2810, within the Cardiovascular review panel as a Class I device.