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FDA 510(k)

AIRLIFE

K-Number: K123527 · 2013-04-25

ApplicantCare Fusion
Decision Date2013-04-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRLIFE is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2013-04-25 under 510(k) number K123527. 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 AIRLIFE?

AIRLIFE is a medical device that received FDA 510(k) clearance on 2013-04-25. The listed applicant is Care Fusion. The 510(k) number is K123527.

When did AIRLIFE receive FDA 510(k) clearance?

AIRLIFE received FDA 510(k) clearance on 2013-04-25, under 510(k) number K123527.

Who is the listed applicant for AIRLIFE?

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

What is the FDA product code for AIRLIFE?

The FDA product code for AIRLIFE is CAF.

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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

View on FDA Database →

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

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