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FDA 510(k)

I-NEB AAD SYSTEM

K-Number: K042991 · 2005-09-23

ApplicantProfile Therapeutics Plc
Decision Date2005-09-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

I-NEB AAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Profile Therapeutics Plc. It received FDA 510(k) clearance on 2005-09-23 under 510(k) number K042991. 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 I-NEB AAD SYSTEM?

I-NEB AAD SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-23. The listed applicant is Profile Therapeutics Plc. The 510(k) number is K042991.

When did I-NEB AAD SYSTEM receive FDA 510(k) clearance?

I-NEB AAD SYSTEM received FDA 510(k) clearance on 2005-09-23, under 510(k) number K042991.

Who is the listed applicant for I-NEB AAD SYSTEM?

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

What is the FDA product code for I-NEB AAD SYSTEM?

The FDA product code for I-NEB AAD SYSTEM is CAF.

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Other records listing Profile Therapeutics Plc 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.

K052941I-NEB INSIGHT AAD SYSTEMK030747PRODOSE AAD 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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