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FDA 510(k)

3D Echo v1.1

K-Number: K211656 · 2021-06-25

ApplicantJointvue, LLC
Decision Date2021-06-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D Echo v1.1 is a medical device manufactured by Jointvue, LLC. It received FDA 510(k) clearance on 2021-06-25 under approval number K211656. 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 3D Echo v1.1?

3D Echo v1.1 is a medical device that received FDA 510(k) clearance on 2021-06-25. It is manufactured by Jointvue, LLC. The 510(k) number is K211656.

When was 3D Echo v1.1 approved by the FDA?

3D Echo v1.1 received FDA 510(k) clearance on 2021-06-25, under approval number K211656.

What company makes 3D Echo v1.1?

3D Echo v1.1 is manufactured by Jointvue, LLC.

What is the FDA product code for 3D Echo v1.1?

The FDA product code for 3D Echo v1.1 is LLZ.

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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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