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FDA 510(k)

qER-Quant

K-Number: K211222 · 2021-07-30

ApplicantQure.Ai Technologies
Decision Date2021-07-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

qER-Quant is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2021-07-30 under approval number K211222. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the qER-Quant?

qER-Quant is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Qure.Ai Technologies. The 510(k) number is K211222.

When was qER-Quant approved by the FDA?

qER-Quant received FDA 510(k) clearance on 2021-07-30, under approval number K211222.

What company makes qER-Quant?

qER-Quant is manufactured by Qure.Ai Technologies.

What is the FDA product code for qER-Quant?

The FDA product code for qER-Quant is QIH.

Other Devices by Qure.Ai Technologies

K200921qER K212690qXR-BT K231805qXR-LN K231149qXR-CTR K230899qXR-PTX-PE K240740qCT LN Quant

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Related Devices (Code: QIH)

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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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