Clearance Summary
Spectra S1Plus and Spectra S2 Plus received FDA 510(k) clearance under submission number K150476, sponsored by Uzinmedicare Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2016-04-15.
- Submission: K150476
- Applicant / Sponsor: Uzinmedicare Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2016-04-15
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.