VENTI-GENTLE-HALER(TM)

Nebulizer (direct Patient Interface)

VORTRAN MEDICAL TECHNOLOGY 1, INC.

The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Venti-gentle-haler(tm).

Pre-market Notification Details

Device IDK933915
510k NumberK933915
Device Name:VENTI-GENTLE-HALER(TM)
ClassificationNebulizer (direct Patient Interface)
Applicant VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST., SUITE 354 Sacramento,  CA  95819
ContactGordon A Wong
CorrespondentGordon A Wong
VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J ST., SUITE 354 Sacramento,  CA  95819
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-10
Decision Date1993-10-28

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