Nephros, Inc., Dsu Dual Stage Ultrafilter
FDA 510(k) K090885 · Nephros, Inc.
510(k) numberK090885
Submission
- Device name
- Nephros, Inc., Dsu Dual Stage Ultrafilter
- Applicant
- Nephros, Inc.
River Edge, NJ, US - Received
- March 31, 2009
- Decision date
- June 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FIP – Subsystem, Water Purification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Nephros, Inc., Dsu Dual Stage Ultrafilter cleared by the FDA?
Nephros, Inc., Dsu Dual Stage Ultrafilter (K090885) received a 510(k) decision of Substantially Equivalent on June 29, 2009, 90 days after the submission was received.
What is the product code of K090885?
The FDA product code is FIP – Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.