FDA 510(k)

decimal3D

K-Number: K192554 · 2019-12-13

Decision Date2019-12-13

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

decimal3D is a medical device manufactured by .Decimal, LLC. It received FDA 510(k) clearance on 2019-12-13 under approval 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. It is manufactured by .Decimal, LLC. The 510(k) number is K192554.

When was decimal3D approved by the FDA?

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

What company makes decimal3D?

decimal3D is manufactured by .Decimal, LLC.

What is the FDA product code for decimal3D?

The FDA product code for decimal3D is MUJ.

Other Devices by .Decimal, LLC

K173940Astroid Planning App K211511decimal Bolus

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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.