Novalung System
K-Number: K191407 · 2020-02-21
Device Summary
Frequently Asked Questions
What is the Novalung System?
Novalung System is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K191407.
When did Novalung System receive FDA 510(k) clearance?
Novalung System received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191407.
Who is the listed applicant for Novalung System?
The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Novalung System?
The FDA product code for Novalung System is QJZ.
Other records listing Fresenius Medical Care Renal Therapies Group, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QJZ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.