CoLumboX
K-Number: K250367 · 2025-05-28
Device Summary
Frequently Asked Questions
What is the CoLumboX?
CoLumboX is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Smart Soft Healthcare AD. The 510(k) number is K250367.
When did CoLumboX receive FDA 510(k) clearance?
CoLumboX received FDA 510(k) clearance on 2025-05-28, under 510(k) number K250367.
Who is the listed applicant for CoLumboX?
The FDA 510(k) record lists Smart Soft Healthcare AD as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoLumboX?
The FDA product code for CoLumboX is QIH.
Other records listing Smart Soft Healthcare AD as applicant
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.
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.
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.