Novalung ultimate kit (US)
K-Number: K232926 · 2024-04-15
Decision Date2024-04-15
Product CodeQJZ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Novalung ultimate kit (US) is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2024-04-15 under approval number K232926. The device is classified under product code QJZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Novalung ultimate kit (US)?
Novalung ultimate kit (US) is a medical device that received FDA 510(k) clearance on 2024-04-15. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K232926.
When was Novalung ultimate kit (US) approved by the FDA?
Novalung ultimate kit (US) received FDA 510(k) clearance on 2024-04-15, under approval number K232926.
What company makes Novalung ultimate kit (US)?
Novalung ultimate kit (US) is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for Novalung ultimate kit (US)?
The FDA product code for Novalung ultimate kit (US) is QJZ.
Related Clinical Trials
Other Devices by Fresenius Medical Care Renal Therapies Group, LLC
Related Devices (Code: QJZ)
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.