VPAP TX

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 Tx.

Pre-market Notification Details

Device IDK113714
510k NumberK113714
Device Name:VPAP TX
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 Received2011-12-19
Decision Date2012-05-25
Summary:summary

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