Clearance Summary
CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311 received FDA 510(k) clearance under submission number K023942, sponsored by Yamato Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-02-24.
- Submission: K023942
- Applicant / Sponsor: Yamato Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2003-02-24
Classification & Regulation
This clearance is catalogued under FDA product code MNW and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.