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FDA 510(k)

ExamVue Duo

K-Number: K213057 · 2022-02-18

ApplicantJpi Healthcare Co, Ltd.
Decision Date2022-02-18
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ExamVue Duo is a medical device manufactured by Jpi Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2022-02-18 under approval number K213057. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExamVue Duo?

ExamVue Duo is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Jpi Healthcare Co, Ltd.. The 510(k) number is K213057.

When was ExamVue Duo approved by the FDA?

ExamVue Duo received FDA 510(k) clearance on 2022-02-18, under approval number K213057.

What company makes ExamVue Duo?

ExamVue Duo is manufactured by Jpi Healthcare Co, Ltd..

What is the FDA product code for ExamVue Duo?

The FDA product code for ExamVue Duo is KPR.

Other Devices by Jpi Healthcare Co, Ltd.

K244010ExamVue Apex

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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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