Clearance Summary
OSADA ENDEX received FDA 510(k) clearance under submission number K904742, sponsored by Osada Electric Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1990-12-17.
- Submission: K904742
- Applicant / Sponsor: Osada Electric Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1990-12-17
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.