VPAP III ST-A

Ventilator, Continuous, Non-life-supporting

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Vpap Iii St-a.

Pre-market Notification Details

Device IDK093731
510k NumberK093731
Device Name:VPAP III ST-A
ClassificationVentilator, Continuous, Non-life-supporting
Applicant RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
ContactDavid D'curz
CorrespondentDavid D'curz
RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
Product CodeMNS  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-03
Decision Date2010-03-22
Summary:summary

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