The following data is part of a premarket notification filed by Nephros Inc. with the FDA for Hydraguard 10 Ultrafilter.
| Device ID | K161467 |
| 510k Number | K161467 |
| Device Name: | HydraGuard 10 UltraFilter |
| Classification | System, Water Purification, General Medical Use |
| Applicant | NEPHROS INC. 41 GRAND AVE River Edge, NJ 07661 |
| Contact | James Summerton |
| Correspondent | Hollie Johnson NEPHROS INC. 41 GRAND AVE River Edge, NJ 07661 |
| Product Code | NHV |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-27 |
| Decision Date | 2016-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20866318000347 | K161467 | 000 |
| 20866318000330 | K161467 | 000 |
| 10866318000326 | K161467 | 000 |