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FDA 510(k)

3D Bolus Software

K-Number: K180289 · 2018-07-10

Applicant3D Bolus, Inc.
Decision Date2018-07-10
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D Bolus Software is a medical device manufactured by 3D Bolus, Inc.. It received FDA 510(k) clearance on 2018-07-10 under approval number K180289. 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 3D Bolus Software?

3D Bolus Software is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by 3D Bolus, Inc.. The 510(k) number is K180289.

When was 3D Bolus Software approved by the FDA?

3D Bolus Software received FDA 510(k) clearance on 2018-07-10, under approval number K180289.

What company makes 3D Bolus Software?

3D Bolus Software is manufactured by 3D Bolus, Inc..

What is the FDA product code for 3D Bolus Software?

The FDA product code for 3D Bolus Software is MUJ.

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Official Source

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