INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)

Nebulizer, Medicinal, Non-ventilatory (atomizer)

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 Intermittent Signal Actuated Nebulizer (visan).

Pre-market Notification Details

Device IDK873477
510k NumberK873477
Device Name:INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)
ClassificationNebulizer, Medicinal, Non-ventilatory (atomizer)
Applicant VORTRAN MEDICAL TECHNOLOGY 1, INC. 1600 SACRAMENTO INN WAY SUITE 132 Sacramento,  CA  95815
ContactWong, M.d.
CorrespondentWong, M.d.
VORTRAN MEDICAL TECHNOLOGY 1, INC. 1600 SACRAMENTO INN WAY SUITE 132 Sacramento,  CA  95815
Product CodeCCQ  
CFR Regulation Number868.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-31
Decision Date1987-10-09

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