eCO2 3D
K-Number: K244060 · 2025-07-31
ApplicantLutronic Corporation
Decision Date2025-07-31
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
eCO2 3D is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2025-07-31 under approval number K244060. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the eCO2 3D?
eCO2 3D is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Lutronic Corporation. The 510(k) number is K244060.
When was eCO2 3D approved by the FDA?
eCO2 3D received FDA 510(k) clearance on 2025-07-31, under approval number K244060.
What company makes eCO2 3D?
eCO2 3D is manufactured by Lutronic Corporation.
What is the FDA product code for eCO2 3D?
The FDA product code for eCO2 3D is ONG.
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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.