S9 GREENHILLS

Ventilator, Non-continuous (respirator)

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for S9 Greenhills.

Pre-market Notification Details

Device IDK140279
510k NumberK140279
Device Name:S9 GREENHILLS
ClassificationVentilator, Non-continuous (respirator)
Applicant RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
ContactJim Cassi
CorrespondentJim Cassi
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 Received2014-02-03
Decision Date2014-07-31
Summary:summary

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