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FDA 510(k)

CoLumbo

K-Number: K220497 · 2022-06-23

ApplicantSmart Soft Healthcare AD
Decision Date2022-06-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoLumbo is a medical device manufactured by Smart Soft Healthcare AD. It received FDA 510(k) clearance on 2022-06-23 under approval number K220497. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoLumbo?

CoLumbo is a medical device that received FDA 510(k) clearance on 2022-06-23. It is manufactured by Smart Soft Healthcare AD. The 510(k) number is K220497.

When was CoLumbo approved by the FDA?

CoLumbo received FDA 510(k) clearance on 2022-06-23, under approval number K220497.

What company makes CoLumbo?

CoLumbo is manufactured by Smart Soft Healthcare AD.

What is the FDA product code for CoLumbo?

The FDA product code for CoLumbo is QIH.

Other Devices by Smart Soft Healthcare AD

K250367CoLumboX K254015CoLumbo C-Spine

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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