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FDA 510(k)

Spectra Cashmere

K-Number: K191208 · 2019-10-11

ApplicantUzinmedicare Co.
Decision Date2019-10-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Spectra Cashmere is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191208. 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 Cashmere?

Spectra Cashmere is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Uzinmedicare Co.. The 510(k) number is K191208.

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

Spectra Cashmere received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191208.

Who is the listed applicant for Spectra Cashmere?

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 Cashmere?

The FDA product code for Spectra Cashmere 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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