NEPHROS DSU-H, NEPHROS SSU-H
FDA 510(k) clearance K141731 · decided 2014-10-24
Clearance details
- K-number
- K141731
- Device name
- NEPHROS DSU-H, NEPHROS SSU-H
- Applicant
- Nephros, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-27
- Decision date
- 2014-10-24
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- NHV
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- River Edge, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.