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FDA 510(k)

Spectra 9Plus

K-Number: K162415 · 2017-03-15

ApplicantUzinmedicare Company
Decision Date2017-03-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Spectra 9Plus is a medical device manufactured by Uzinmedicare Company. It received FDA 510(k) clearance on 2017-03-15 under approval number K162415. 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 9Plus?

Spectra 9Plus is a medical device that received FDA 510(k) clearance on 2017-03-15. It is manufactured by Uzinmedicare Company. The 510(k) number is K162415.

When was Spectra 9Plus approved by the FDA?

Spectra 9Plus received FDA 510(k) clearance on 2017-03-15, under approval number K162415.

What company makes Spectra 9Plus?

Spectra 9Plus is manufactured by Uzinmedicare Company.

What is the FDA product code for Spectra 9Plus?

The FDA product code for Spectra 9Plus is HGX.

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Official Source

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

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