VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM

Ventilator, Emergency, Powered (resuscitator)

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 Var-plus (vortran Automatic Resuscitator), Model Pcm.

Pre-market Notification Details

Device IDK041473
510k NumberK041473
Device Name:VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant VORTRAN MEDICAL TECHNOLOGY 1, INC. 1804 TRIBUTE RD., SUITE F Sacramento,  CA  95815
ContactJames Lee
CorrespondentJames Lee
VORTRAN MEDICAL TECHNOLOGY 1, INC. 1804 TRIBUTE RD., SUITE F Sacramento,  CA  95815
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-02
Decision Date2004-07-15
Summary:summary

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