Clearance Summary
ESG-1 ELECTROSONOGRAM (ESG-1) received FDA 510(k) clearance under submission number K970116, sponsored by Myo-Tronics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-04-02.
- Submission: K970116
- Applicant / Sponsor: Myo-Tronics, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.2050
- Decision date: 1997-04-02
Classification & Regulation
This clearance is catalogued under FDA product code NFQ and 21 CFR 872.2050, within the Dental review panel as a Class I device.