Clearance Summary
EMS-200 received FDA 510(k) clearance under submission number K153285, sponsored by Meta Systems Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-08-12.
- Submission: K153285
- Applicant / Sponsor: Meta Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2016-08-12
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.