AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT

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 Autoneb Breath Actuated Controller And Accessory Kit.

Pre-market Notification Details

Device IDK935693
510k NumberK935693
Device Name:AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
ClassificationNebulizer (direct Patient Interface)
Applicant VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J STREET, SUITE 354 Sacramento,  CA  95819
ContactGordon A Wong, M.d.
CorrespondentGordon A Wong, M.d.
VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J STREET, SUITE 354 Sacramento,  CA  95819
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-29
Decision Date1994-08-25

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