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FDA 510(k)

CoLumbo

K-Number: K241211 · 2024-08-15

ApplicantSmart Soft Healthcare
Decision Date2024-08-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoLumbo is a medical device manufactured by Smart Soft Healthcare. It received FDA 510(k) clearance on 2024-08-15 under approval number K241211. 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 2024-08-15. It is manufactured by Smart Soft Healthcare. The 510(k) number is K241211.

When was CoLumbo approved by the FDA?

CoLumbo received FDA 510(k) clearance on 2024-08-15, under approval number K241211.

What company makes CoLumbo?

CoLumbo is manufactured by Smart Soft Healthcare.

What is the FDA product code for CoLumbo?

The FDA product code for CoLumbo is QIH.

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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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