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FDA 510(k)

Aerogen®Solo Nebulizer System

K-Number: K232507 · 2024-05-10

ApplicantAerogen, Ltd.
Decision Date2024-05-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Aerogen®Solo Nebulizer System is the device name listed in this FDA 510(k) record. The listed applicant is Aerogen, Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) 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. The listed applicant is Aerogen, Ltd.. The 510(k) number is K232507.

When did Aerogen®Solo Nebulizer System receive FDA 510(k) clearance?

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

Who is the listed applicant for Aerogen®Solo Nebulizer System?

The FDA 510(k) record lists Aerogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07791992Combination of High-flow Nasal Oxygen (Optiflow) and Vibrating Membrane Nebuliser (Aerogen) in the Pre-hospital Setting - Before/After StudyWITHDRAWN

Other records listing Aerogen, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251615Aerogen Pro-X1 Controller System

Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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