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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 the device name listed in this FDA 510(k) record. The listed applicant is Smart Soft Healthcare. It received FDA 510(k) clearance on 2024-08-15 under 510(k) 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. The listed applicant is Smart Soft Healthcare. The 510(k) number is K241211.

When did CoLumbo receive FDA 510(k) clearance?

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

Who is the listed applicant for CoLumbo?

The FDA 510(k) record lists Smart Soft Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLumbo?

The FDA product code for CoLumbo is QIH.

Related Devices (Code: QIH)

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

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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