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FDA 510(k)

Imbio RV/LV Software

K-Number: K203256 · 2021-03-09

ApplicantImbio, LLC
Decision Date2021-03-09
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Imbio RV/LV Software is a medical device manufactured by Imbio, LLC. It received FDA 510(k) clearance on 2021-03-09 under approval number K203256. 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 Imbio RV/LV Software?

Imbio RV/LV Software is a medical device that received FDA 510(k) clearance on 2021-03-09. It is manufactured by Imbio, LLC. The 510(k) number is K203256.

When was Imbio RV/LV Software approved by the FDA?

Imbio RV/LV Software received FDA 510(k) clearance on 2021-03-09, under approval number K203256.

What company makes Imbio RV/LV Software?

Imbio RV/LV Software is manufactured by Imbio, LLC.

What is the FDA product code for Imbio RV/LV Software?

The FDA product code for Imbio RV/LV Software is QIH.

Other Devices by Imbio, LLC

K180129Imbio Segmentation Editing Tool software

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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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