Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

I-NEB INSIGHT AAD SYSTEM

K-Number: K052941 · 2005-12-09

ApplicantProfile Therapeutics Plc
Decision Date2005-12-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

I-NEB INSIGHT 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 2005-12-09 under 510(k) number K052941. 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 INSIGHT AAD SYSTEM?

I-NEB INSIGHT AAD SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Profile Therapeutics Plc. The 510(k) number is K052941.

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

I-NEB INSIGHT AAD SYSTEM received FDA 510(k) clearance on 2005-12-09, under 510(k) number K052941.

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

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K042991I-NEB 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

View on FDA Database →

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

↑