Novalung System

Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure

Fresenius Medical Care Renal Therapies Group, LLC

The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Novalung System.

Pre-market Notification Details

Device IDK191407
510k NumberK191407
Device Name:Novalung System
ClassificationExtracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Applicant Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
Product CodeQJZ  
CFR Regulation Number870.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-28
Decision Date2020-02-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04057224902043 K191407 000
04057224001494 K191407 000

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