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)

800 SERIES EASYNEB NEBULIZER

K-Number: K020357 · 2002-08-07

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2002-08-07
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

800 SERIES EASYNEB NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2002-08-07 under 510(k) number K020357. 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 800 SERIES EASYNEB NEBULIZER?

800 SERIES EASYNEB NEBULIZER is a medical device that received FDA 510(k) clearance on 2002-08-07. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K020357.

When did 800 SERIES EASYNEB NEBULIZER receive FDA 510(k) clearance?

800 SERIES EASYNEB NEBULIZER received FDA 510(k) clearance on 2002-08-07, under 510(k) number K020357.

Who is the listed applicant for 800 SERIES EASYNEB NEBULIZER?

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

What is the FDA product code for 800 SERIES EASYNEB NEBULIZER?

The FDA product code for 800 SERIES EASYNEB NEBULIZER 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 Nellcor Puritan Bennett, 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.

K070408DURAMAX REUSABLE OXIMETRY SENSORK060576NELLCOR OXIMAX N-600X PULSE OXIMETERK051271OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSORK052186NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-PK051352OXIMAX NPB-40 HANDHELD PULSE OXIMETERK050072GOODKNIGHT 425ST

View all 42 devices →

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.

↑