MC 300R* Nebulizer

Nebulizer (direct Patient Interface)

Trudell Medical International

The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Mc 300r* Nebulizer.

Pre-market Notification Details

Device IDK173825
510k NumberK173825
Device Name:MC 300R* Nebulizer
ClassificationNebulizer (direct Patient Interface)
Applicant Trudell Medical International 725 Third Street London,  CA N5v 5g4
ContactMarianne Tanton
CorrespondentMarianne Tanton
Trudell Medical International 725 Third Street London,  CA N5v 5g4
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-18
Decision Date2018-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
62860105552022 K173825 000
00762860055520 K173825 000

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