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FDA 510(k)

AERONEB GO NEBULIZER

K-Number: K081650 · 2008-10-23

ApplicantAerogen (Ireland), Ltd.
Decision Date2008-10-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AERONEB GO NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Aerogen (Ireland), Ltd.. It received FDA 510(k) clearance on 2008-10-23 under 510(k) number K081650. 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 AERONEB GO NEBULIZER?

AERONEB GO NEBULIZER is a medical device that received FDA 510(k) clearance on 2008-10-23. The listed applicant is Aerogen (Ireland), Ltd.. The 510(k) number is K081650.

When did AERONEB GO NEBULIZER receive FDA 510(k) clearance?

AERONEB GO NEBULIZER received FDA 510(k) clearance on 2008-10-23, under 510(k) number K081650.

Who is the listed applicant for AERONEB GO NEBULIZER?

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

What is the FDA product code for AERONEB GO NEBULIZER?

The FDA product code for AERONEB GO NEBULIZER is CAF.

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Other records listing Aerogen (Ireland), 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.

K102240NIVO NEBULIZER SYSTEMK070642AERONEB PROFESSIONAL NEBULIZER SYSTEM

Related Devices (Code: CAF)

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Official Source

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