Atmo Gas Capsule System
K-Number: K250940 · 2025-06-26
ApplicantAtmo Biosciences, Ltd.
Decision Date2025-06-26
Product CodeNYV
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Atmo Gas Capsule System is a medical device manufactured by Atmo Biosciences, Ltd.. It received FDA 510(k) clearance on 2025-06-26 under approval number K250940. The device is classified under product code NYV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atmo Gas Capsule System?
Atmo Gas Capsule System is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Atmo Biosciences, Ltd.. The 510(k) number is K250940.
When was Atmo Gas Capsule System approved by the FDA?
Atmo Gas Capsule System received FDA 510(k) clearance on 2025-06-26, under approval number K250940.
What company makes Atmo Gas Capsule System?
Atmo Gas Capsule System is manufactured by Atmo Biosciences, Ltd..
What is the FDA product code for Atmo Gas Capsule System?
The FDA product code for Atmo Gas Capsule System is NYV.
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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.