LTV-1000 VENTILATOR

Ventilator, Continuous, Facility Use

PULMONETIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Pulmonetic Systems, Inc. with the FDA for Ltv-1000 Ventilator.

Pre-market Notification Details

Device IDK032226
510k NumberK032226
Device Name:LTV-1000 VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant PULMONETIC SYSTEMS, INC. 17400 MEDINA RD. SUITE 100 Minneapolis,  MN  55447
ContactRobert C Samec
CorrespondentRobert C Samec
PULMONETIC SYSTEMS, INC. 17400 MEDINA RD. SUITE 100 Minneapolis,  MN  55447
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-21
Decision Date2003-10-16

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