Aerogen Pro-X1 Controller System
K-Number: K251615 · 2025-09-02
ApplicantAerogen, Ltd.
Decision Date2025-09-02
Product CodeSFP
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Aerogen Pro-X1 Controller System is a medical device manufactured by Aerogen, Ltd.. It received FDA 510(k) clearance on 2025-09-02 under approval number K251615. The device is classified under product code SFP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aerogen Pro-X1 Controller System?
Aerogen Pro-X1 Controller System is a medical device that received FDA 510(k) clearance on 2025-09-02. It is manufactured by Aerogen, Ltd.. The 510(k) number is K251615.
When was Aerogen Pro-X1 Controller System approved by the FDA?
Aerogen Pro-X1 Controller System received FDA 510(k) clearance on 2025-09-02, under approval number K251615.
What company makes Aerogen Pro-X1 Controller System?
Aerogen Pro-X1 Controller System is manufactured by Aerogen, Ltd..
What is the FDA product code for Aerogen Pro-X1 Controller System?
The FDA product code for Aerogen Pro-X1 Controller System is SFP.
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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.