Proneb Max

Nebulizer (direct Patient Interface)

PARI Respiratory Equipment, Inc.

The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for Proneb Max.

Pre-market Notification Details

Device IDK191270
510k NumberK191270
Device Name:Proneb Max
ClassificationNebulizer (direct Patient Interface)
Applicant PARI Respiratory Equipment, Inc. 2412 PARI Way Midlothian,  VA  23112
ContactMichael Judge
CorrespondentMichael Judge
PARI Respiratory Equipment, Inc. 2412 PARI Way Midlothian,  VA  23112
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-13
Decision Date2020-01-23
Summary:summary

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