Clearance Summary
ROOT ZX received FDA 510(k) clearance under submission number K921979, sponsored by J. Morita USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1993-05-27.
- Submission: K921979
- Applicant / Sponsor: J. Morita USA, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1993-05-27
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.