FDA 510(k)

CFR QUANT

K-Number: K113754 · 2012-07-19

ApplicantUniversity of Texas Medical School AT Houston

Decision Date2012-07-19

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CFR QUANT is the device name listed in this FDA 510(k) record. The listed applicant is University of Texas Medical School AT Houston. It received FDA 510(k) clearance on 2012-07-19 under 510(k) number K113754. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CFR QUANT?

CFR QUANT is a medical device that received FDA 510(k) clearance on 2012-07-19. The listed applicant is University of Texas Medical School AT Houston. The 510(k) number is K113754.

When did CFR QUANT receive FDA 510(k) clearance?

CFR QUANT received FDA 510(k) clearance on 2012-07-19, under 510(k) number K113754.

Who is the listed applicant for CFR QUANT?

The FDA 510(k) record lists University of Texas Medical School AT Houston as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CFR QUANT?

The FDA product code for CFR QUANT is KPS.

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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.