VPAP 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 St-a.

Pre-market Notification Details

Device IDK113288
510k NumberK113288
Device Name:VPAP ST-A
ClassificationVentilator, Continuous, Non-life-supporting
Applicant RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
ContactDavid D'cruz
CorrespondentDavid D'cruz
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 Received2011-11-07
Decision Date2012-03-29
Summary:summary

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