FDA 510(k)

Segment 3DPrint

K-Number: K211966 · 2022-05-06

Decision Date2022-05-06

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Segment 3DPrint is the device name listed in this FDA 510(k) record. The listed applicant is Medviso AB. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K211966. 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 Segment 3DPrint?

Segment 3DPrint is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Medviso AB. The 510(k) number is K211966.

When did Segment 3DPrint receive FDA 510(k) clearance?

Segment 3DPrint received FDA 510(k) clearance on 2022-05-06, under 510(k) number K211966.

Who is the listed applicant for Segment 3DPrint?

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

What is the FDA product code for Segment 3DPrint?

The FDA product code for Segment 3DPrint is LLZ.

Other records listing Medviso AB 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.

K163076Segment CMR

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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.