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510(k) K191407

Device
Novalung System
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
510(k) number
K191407
Product code
QJZ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-21
Date received
2019-05-28
Regulation
870.4100
Classification name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Denise Oppermann
Address
920 Winter St. Waltham MA US 02451 02451

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QJZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.2024-09-12
K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC2024-04-15

Legacy Summary#

summary

FDA Review#

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