FDA 510(k)

INTDose

K-Number: K213137 · 2022-05-13

Decision Date2022-05-13

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

INTDose is the device name listed in this FDA 510(k) record. The listed applicant is Carina Medical, LLC. It received FDA 510(k) clearance on 2022-05-13 under 510(k) 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. The listed applicant is Carina Medical, LLC. The 510(k) number is K213137.

When did INTDose receive FDA 510(k) clearance?

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

Who is the listed applicant for INTDose?

The FDA 510(k) record lists Carina Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTDose?

The FDA product code for INTDose is IYE.

Other records listing Carina Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.