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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 a medical device manufactured by Trudell Medical International. It received FDA 510(k) clearance on 2018-05-02 under approval 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. It is manufactured by Trudell Medical International. The 510(k) number is K173825.

When was MC 300R* Nebulizer approved by the FDA?

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

What company makes MC 300R* Nebulizer?

MC 300R* Nebulizer is manufactured by Trudell Medical International.

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

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

Other Devices by Trudell Medical International

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Related Devices (Code: CAF)

K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation K153010Hudson RCI AquaPak Sterile Prefilled NebulizersTeleflexmedical, Inc. K152882Propeller SystemReciprocal Labs K152482Propeller Sensor Model 2014-RReciprocal Labs K142541POCKET NEBMicrovaper Devices K170916Portable NebulizerMicrobase Technology Corporation

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.

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