Olpur Dialyzer, Model HD 190
FDA 510(k) K050603 · Nephros, Inc.
510(k) numberK050603
Submission
- Device name
- Olpur Dialyzer, Model HD 190
- Applicant
- Nephros, Inc.
New York, NY, US - Received
- March 9, 2005
- Decision date
- June 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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Questions and answers
When was Olpur Dialyzer, Model HD 190 cleared by the FDA?
Olpur Dialyzer, Model HD 190 (K050603) received a 510(k) decision of Substantially Equivalent on June 9, 2005, 92 days after the submission was received.
What is the product code of K050603?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.