RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000

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 Respirtech Pro-o2c, Model 2200 And Respirtech Pro, Model 2000.

Pre-market Notification Details

Device IDK001430
510k NumberK001430
Device Name:RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
ClassificationVentilator, Emergency, Powered (resuscitator)
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 CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-05
Decision Date2000-07-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.