RESSCAN

Ventilator, Continuous, Non-life-supporting

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Resscan.

Pre-market Notification Details

Device IDK113815
510k NumberK113815
Device Name:RESSCAN
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  
Subsequent Product CodeBZD
Subsequent Product CodeMNT
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-23
Decision Date2012-03-27
Summary:summary

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