510(k) K191407
K191407 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Novalung System". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure), a Class II device regulated under 21 CFR 870.4100. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2020
- Date Received
- May 28, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- Device Class
- Class II
- Regulation Number
- 870.4100
- Review Panel
- CV
- Submission Type
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.