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FDA 510(k)

Spectra S1Plus and Spectra S2 Plus

K-Number: K150476 · 2016-04-15

ApplicantUzinmedicare Co.
Decision Date2016-04-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Spectra S1Plus and Spectra S2 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K150476. 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 S1Plus and Spectra S2 Plus?

Spectra S1Plus and Spectra S2 Plus is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Uzinmedicare Co.. The 510(k) number is K150476.

When did Spectra S1Plus and Spectra S2 Plus receive FDA 510(k) clearance?

Spectra S1Plus and Spectra S2 Plus received FDA 510(k) clearance on 2016-04-15, under 510(k) number K150476.

Who is the listed applicant for Spectra S1Plus and Spectra S2 Plus?

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 S1Plus and Spectra S2 Plus?

The FDA product code for Spectra S1Plus and Spectra S2 Plus is HGX.

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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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