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FDA 510(k)

AERONEB PORTABLE NEBULIZER

K-Number: K003022 · 2000-10-13

ApplicantAerogen, Inc.
Decision Date2000-10-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AERONEB PORTABLE NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Aerogen, Inc.. It received FDA 510(k) clearance on 2000-10-13 under 510(k) number K003022. 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 PORTABLE NEBULIZER?

AERONEB PORTABLE NEBULIZER is a medical device that received FDA 510(k) clearance on 2000-10-13. The listed applicant is Aerogen, Inc.. The 510(k) number is K003022.

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

AERONEB PORTABLE NEBULIZER received FDA 510(k) clearance on 2000-10-13, under 510(k) number K003022.

Who is the listed applicant for AERONEB PORTABLE NEBULIZER?

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

What is the FDA product code for AERONEB PORTABLE NEBULIZER?

The FDA product code for AERONEB PORTABLE NEBULIZER is CAF.

Related Clinical Trials

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Other records listing Aerogen, Inc. 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.

K032849AERONEB GO NEBULIZER, MODEL AG-AG2000K021175AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000K992831AERONEB II, MODEL APN 200

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

Official Source

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