U-MID PREFILLED NEBULIZER

Nebulizer (direct Patient Interface)

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for U-mid Prefilled Nebulizer.

Pre-market Notification Details

Device IDK760585
510k NumberK760585
Device Name:U-MID PREFILLED NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington,  DC  20006
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-09-03
Decision Date1976-10-15

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