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FDA 510(k)

NIVO NEBULIZER SYSTEM

K-Number: K102240 · 2010-11-10

ApplicantAerogen Ireland, Ltd.
Decision Date2010-11-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NIVO NEBULIZER SYSTEM 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 2010-11-10 under 510(k) number K102240. 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 NIVO NEBULIZER SYSTEM?

NIVO NEBULIZER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-10. The listed applicant is Aerogen Ireland, Ltd.. The 510(k) number is K102240.

When did NIVO NEBULIZER SYSTEM receive FDA 510(k) clearance?

NIVO NEBULIZER SYSTEM received FDA 510(k) clearance on 2010-11-10, under 510(k) number K102240.

Who is the listed applicant for NIVO NEBULIZER SYSTEM?

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 NIVO NEBULIZER SYSTEM?

The FDA product code for NIVO NEBULIZER SYSTEM 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.

K081650AERONEB GO NEBULIZERK070642AERONEB PROFESSIONAL NEBULIZER 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.

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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