PreOp v3
K-Number: K252565 · 2026-02-13
ApplicantClouds of Care
Decision Date2026-02-13
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
PreOp v3 is a medical device manufactured by Clouds of Care. It received FDA 510(k) clearance on 2026-02-13 under approval number K252565. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PreOp v3?
PreOp v3 is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Clouds of Care. The 510(k) number is K252565.
When was PreOp v3 approved by the FDA?
PreOp v3 received FDA 510(k) clearance on 2026-02-13, under approval number K252565.
What company makes PreOp v3?
PreOp v3 is manufactured by Clouds of Care.
What is the FDA product code for PreOp v3?
The FDA product code for PreOp v3 is OLX.
Related Devices (Code: OLX)
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.