meddevicedb.com FDA Device Reference

MINUET LCD, MINUET LCD eco

K180075 Class II Traditional
Decision Date
2018-08-06
Sponsor / Applicant
Unimom.Co

Technical Specification

510(k) Submission ID K180075
Product Code HGX
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5160
Decision Date 2018-08-06
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MINUET LCD, MINUET LCD eco received FDA 510(k) clearance under submission number K180075, sponsored by Unimom.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 2018-08-06.

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.