Aerogen Pro-X1 Controller System— 510(k) K251615

Substantially Equivalent

Aerogen, Ltd.

FDA 510(k) clearance K251615 for Aerogen Pro-X1 Controller System, Substantially Equivalent on 2025-09-02. Applicant: Aerogen, Ltd.. Device class: 2.

Clearance details

Applicant: Aerogen, Ltd.
Product code: Code SFP
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2025-05-27
Decision date: 2025-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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