Spectra Q

by Uzinmedicare South Korea 510(k)

510(k) K191109

Product code HGX

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK191109	Date22 Jan 2020Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K191109
FDA Product Code: HGX
FDA applicant: Uzinmedicare Co.

Device Class: Class II
Regulation: 21 CFR Part 884.5160
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K191109 24 fields · synced 22 Oct 2026