FDA 510(k)

CuraRad-ICH

K-Number: K192167 · 2020-04-13

Decision Date2020-04-13

Product CodeQAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CuraRad-ICH is the device name listed in this FDA 510(k) record. The listed applicant is Curacloud Corp.. It received FDA 510(k) clearance on 2020-04-13 under 510(k) number K192167. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CuraRad-ICH?

CuraRad-ICH is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Curacloud Corp.. The 510(k) number is K192167.

When did CuraRad-ICH receive FDA 510(k) clearance?

CuraRad-ICH received FDA 510(k) clearance on 2020-04-13, under 510(k) number K192167.

Who is the listed applicant for CuraRad-ICH?

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

What is the FDA product code for CuraRad-ICH?

The FDA product code for CuraRad-ICH is QAS.

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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.