Clearance Summary
Nissha Medical Technologies Neutral Electrodes received FDA 510(k) clearance under submission number K203494, sponsored by Nissha Medical Technologies, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-02-23.
- Submission: K203494
- Applicant / Sponsor: Nissha Medical Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2021-02-23
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.