FDA 510(k)

Aerogen®Solo Nebulizer System

K-Number: K232507 · 2024-05-10

Decision Date2024-05-10

Product CodeCAF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Aerogen®Solo Nebulizer System is a medical device manufactured by Aerogen, Ltd.. It received FDA 510(k) clearance on 2024-05-10 under approval number K232507. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aerogen®Solo Nebulizer System?

Aerogen®Solo Nebulizer System is a medical device that received FDA 510(k) clearance on 2024-05-10. It is manufactured by Aerogen, Ltd.. The 510(k) number is K232507.

When was Aerogen®Solo Nebulizer System approved by the FDA?

Aerogen®Solo Nebulizer System received FDA 510(k) clearance on 2024-05-10, under approval number K232507.

What company makes Aerogen®Solo Nebulizer System?

Aerogen®Solo Nebulizer System is manufactured by Aerogen, Ltd..

What is the FDA product code for Aerogen®Solo Nebulizer System?

The FDA product code for Aerogen®Solo Nebulizer System is CAF.

Related Clinical Trials

NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING

Other Devices by Aerogen, Ltd.

K251615Aerogen Pro-X1 Controller System

Related Devices (Code: CAF)

K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation K153010Hudson RCI AquaPak Sterile Prefilled NebulizersTeleflexmedical, Inc. K152882Propeller SystemReciprocal Labs K152482Propeller Sensor Model 2014-RReciprocal Labs K142541POCKET NEBMicrovaper Devices K170916Portable NebulizerMicrobase Technology Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.