BreatheSuite MDI V1

Nebulizer (direct Patient Interface)

BreatheSuite Inc

The following data is part of a premarket notification filed by Breathesuite Inc with the FDA for Breathesuite Mdi V1.

Pre-market Notification Details

Device IDK203155
510k NumberK203155
Device Name:BreatheSuite MDI V1
ClassificationNebulizer (direct Patient Interface)
Applicant BreatheSuite Inc 29 Rowan Street Unit 2 St. John's,  CA A1b2x2
ContactBrett Vokey
CorrespondentBrett Vokey
BreatheSuite Inc 29 Rowan Street Unit 2 St. John's,  CA A1b2x2
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-22
Decision Date2021-09-17

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