AeroEclipse* ONE BAN

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 Aeroeclipse* One Ban.

Pre-market Notification Details

Device IDK200063
510k NumberK200063
Device Name:AeroEclipse* ONE BAN
ClassificationNebulizer (direct Patient Interface)
Applicant Trudell Medical International 725 Baransway Drive London,  CA N5v 5g4
ContactMarianne Tanton
CorrespondentMarianne Tanton
Trudell Medical International 725 Baransway Drive London,  CA N5v 5g4
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-13
Decision Date2020-07-17

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