S9 VPAP ST WITH H5I

Ventilator, Non-continuous (respirator)

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for S9 Vpap St With H5i.

Pre-market Notification Details

Device IDK102513
510k NumberK102513
Device Name:S9 VPAP ST WITH H5I
ClassificationVentilator, Non-continuous (respirator)
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 CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-01
Decision Date2011-01-05
Summary:summary

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