FDA 510(k)

3D Echo v1.1

K-Number: K211656 · 2021-06-25

Decision Date2021-06-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3D Echo v1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Jointvue, LLC. It received FDA 510(k) clearance on 2021-06-25 under 510(k) 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. The listed applicant is Jointvue, LLC. The 510(k) number is K211656.

When did 3D Echo v1.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for 3D Echo v1.1?

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

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

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

Other records listing Jointvue, 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.

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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.