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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 the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Company. It received FDA 510(k) clearance on 2017-03-15 under 510(k) 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. The listed applicant is Uzinmedicare Company. The 510(k) number is K162415.

When did Spectra 9Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for Spectra 9Plus?

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

What is the FDA product code for Spectra 9Plus?

The FDA product code for Spectra 9Plus 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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