The following data is part of a premarket notification filed by Nephros, Inc. with the FDA for Nephros Dsu-h, Nephros Ssu-h.
| Device ID | K141731 |
| 510k Number | K141731 |
| Device Name: | NEPHROS DSU-H, NEPHROS SSU-H |
| Classification | System, Water Purification, General Medical Use |
| Applicant | NEPHROS, INC. 41 GRAND AVE River Edge, NJ 07661 |
| Contact | James Summerton |
| Correspondent | James Summerton NEPHROS, INC. 41 GRAND AVE River Edge, NJ 07661 |
| Product Code | NHV |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-27 |
| Decision Date | 2014-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10896241002357 | K141731 | 000 |
| 10896241002104 | K141731 | 000 |
| 10896241002319 | K141731 | 000 |
| 10896241002371 | K141731 | 000 |
| 10896241002388 | K141731 | 000 |
| 10896241002401 | K141731 | 000 |
| 10896241002326 | K141731 | 000 |
| 10896241002333 | K141731 | 000 |
| 10896241002340 | K141731 | 000 |
| 10896241002098 | K141731 | 000 |