FDA 510(k)

Caas Qardia

K-Number: K212376 · 2022-05-16

Decision Date2022-05-16

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Caas Qardia is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K212376. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Caas Qardia?

Caas Qardia is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K212376.

When did Caas Qardia receive FDA 510(k) clearance?

Caas Qardia received FDA 510(k) clearance on 2022-05-16, under 510(k) number K212376.

Who is the listed applicant for Caas Qardia?

The FDA 510(k) record lists Pie Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Caas Qardia?

The FDA product code for Caas Qardia is LLZ.

Other records listing Pie Medical Imaging BV as applicant

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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.