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)

MC 300R* Nebulizer

K-Number: K173825 · 2018-05-02

ApplicantTrudell Medical International
Decision Date2018-05-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MC 300R* Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2018-05-02 under 510(k) number K173825. 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 MC 300R* Nebulizer?

MC 300R* Nebulizer is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Trudell Medical International. The 510(k) number is K173825.

When did MC 300R* Nebulizer receive FDA 510(k) clearance?

MC 300R* Nebulizer received FDA 510(k) clearance on 2018-05-02, under 510(k) number K173825.

Who is the listed applicant for MC 300R* Nebulizer?

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

What is the FDA product code for MC 300R* Nebulizer?

The FDA product code for MC 300R* Nebulizer is CAF.

Other records listing Trudell Medical International 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.

K242667AeroChamber2go Anti-Static Valved Holding ChamberK203400Corrugated tube with mouthpiece accessoryK200063AeroEclipse* ONE BANK183108Combined Aerobika OPEP and VersaPAP deviceK181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)K173918VersaPAP Positive Airway Pressure (PAP) Device

View all 8 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.

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.K250022HeroTracker SenseVoluntis

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.

↑