FDA 510(k)

INTDose

K-Number: K213137 · 2022-05-13

Decision Date2022-05-13

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

INTDose is a medical device manufactured by Carina Medical, LLC. It received FDA 510(k) clearance on 2022-05-13 under approval number K213137. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTDose?

INTDose is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Carina Medical, LLC. The 510(k) number is K213137.

When was INTDose approved by the FDA?

INTDose received FDA 510(k) clearance on 2022-05-13, under approval number K213137.

What company makes INTDose?

INTDose is manufactured by Carina Medical, LLC.

What is the FDA product code for INTDose?

The FDA product code for INTDose is IYE.

Other Devices by Carina Medical, LLC

K212274INT Contour

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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.