HydraGuard 10 UltraFilter— 510(k) K161467
Substantially EquivalentNephros, Inc.
FDA 510(k) clearance K161467 for HydraGuard 10 UltraFilter, Substantially Equivalent on 2016-12-22. Applicant: Nephros, Inc.. Device class: 2.
Clearance details
- Applicant
- Nephros, Inc.
- Product code
- Code NHV
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- River Edge, NJ, US
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More clearances from Nephros, Inc.
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