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)

LUNG AEROSOL UNIT

K-Number: K800023 · 1985-01-01

ApplicantCadema Medical Products, Inc.
Decision Date1985-01-01
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LUNG AEROSOL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Cadema Medical Products, Inc.. It received FDA 510(k) clearance on 1985-01-01 under 510(k) number K800023. 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 LUNG AEROSOL UNIT?

LUNG AEROSOL UNIT is a medical device that received FDA 510(k) clearance on 1985-01-01. The listed applicant is Cadema Medical Products, Inc.. The 510(k) number is K800023.

When did LUNG AEROSOL UNIT receive FDA 510(k) clearance?

LUNG AEROSOL UNIT received FDA 510(k) clearance on 1985-01-01, under 510(k) number K800023.

Who is the listed applicant for LUNG AEROSOL UNIT?

The FDA 510(k) record lists Cadema Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUNG AEROSOL UNIT?

The FDA product code for LUNG AEROSOL UNIT 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 Cadema Medical Products, 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.

K901476MODIFIED ENTRAPPING FILTERK896773DISPOSABLE FACE MASKK896116ENTRAPPING FILTERK881812AERO-MIST NEBULIZERK873930AEROSOL DELIVERY SYSTEM (AERO-TECH II)

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.

↑