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)

SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)

K-Number: K123614 · 2013-03-11

ApplicantTrudell Medical Intl.
Decision Date2013-03-11
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical Intl.. It received FDA 510(k) clearance on 2013-03-11 under 510(k) number K123614. 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 SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)?

SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) is a medical device that received FDA 510(k) clearance on 2013-03-11. The listed applicant is Trudell Medical Intl.. The 510(k) number is K123614.

When did SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) receive FDA 510(k) clearance?

SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) received FDA 510(k) clearance on 2013-03-11, under 510(k) number K123614.

Who is the listed applicant for SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)?

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

What is the FDA product code for SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)?

The FDA product code for SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) 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 Trudell Medical Intl. 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.

K131881OMBRA TABLE TOP COMPRESSORK123400AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICEK112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)K110136RESPICHAMBER VALVED HOLDING CHAMBERK090065AEROCHAMBER MINI VENTILATION CHAMBERK080926AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER

View all 12 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.

↑