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FDA 510(k), K191407, Novalung System
FDA 510(k), K191407, Novalung System
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510(K) Number: K191407
Device Name: Novalung System
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Device Classification Name: extracorporeal system for long-term respiratory / cardiopulmonary failure
Regulation Number: 870.4100
Classification Product Code: QJZ
Date Received: 05/28/2019
Decision Date: 02/21/2020
Regulation Medical Specialty: Cardiovascular
Device Name: Novalung System
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Device Classification Name: extracorporeal system for long-term respiratory / cardiopulmonary failure
Regulation Number: 870.4100
Classification Product Code: QJZ
Date Received: 05/28/2019
Decision Date: 02/21/2020
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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