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 IDK033276
510k NumberK033276
Device Name:VPAP III ST-A
ClassificationVentilator, Continuous, Non-life-supporting
Applicant RESMED LTD. 14040 DANIELSON ST. Poway,  CA  92064 -6857
ContactDavid D'cruz
CorrespondentDavid D'cruz
RESMED LTD. 14040 DANIELSON ST. Poway,  CA  92064 -6857
Product CodeMNS  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-10
Decision Date2004-06-07
Summary:summary

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