Clearance Summary
Synergy Gold (SG) Portable (Models MM011450 and MM011460) received FDA 510(k) clearance under submission number K210124, sponsored by Uzinmedicare Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2021-10-19.
- Submission: K210124
- Applicant / Sponsor: Uzinmedicare Co.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2021-10-19
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.