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FDA 510(k)

Spectra Q

K-Number: K191109 · 2020-01-22

ApplicantUzinmedicare Co.
Decision Date2020-01-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Spectra Q is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K191109. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectra Q?

Spectra Q is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Uzinmedicare Co.. The 510(k) number is K191109.

When did Spectra Q receive FDA 510(k) clearance?

Spectra Q received FDA 510(k) clearance on 2020-01-22, under 510(k) number K191109.

Who is the listed applicant for Spectra Q?

The FDA 510(k) record lists Uzinmedicare Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spectra Q?

The FDA product code for Spectra Q is HGX.

Other records listing Uzinmedicare Co. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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