Clearance Summary
NEOSONO 2000 received FDA 510(k) clearance under submission number K955088, sponsored by American Medical & Dental Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1996-07-10.
- Submission: K955088
- Applicant / Sponsor: American Medical & Dental Corp.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1996-07-10
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.