FDA 510(k)

decimal3D

K-Number: K192554 · 2019-12-13

Decision Date2019-12-13

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

decimal3D is the device name listed in this FDA 510(k) record. The listed applicant is .Decimal, LLC. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192554. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the decimal3D?

decimal3D is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is .Decimal, LLC. The 510(k) number is K192554.

When did decimal3D receive FDA 510(k) clearance?

decimal3D received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192554.

Who is the listed applicant for decimal3D?

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

What is the FDA product code for decimal3D?

The FDA product code for decimal3D is MUJ.

Other records listing .Decimal, 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.