The following data is part of a premarket notification filed by Nephros Inc. with the FDA for Nephros S100.
| Device ID | K153084 |
| 510k Number | K153084 |
| Device Name: | Nephros S100 |
| 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 | 2015-10-26 |
| Decision Date | 2016-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10896241002562 | K153084 | 000 |
| 10896241002555 | K153084 | 000 |
| 00896241002541 | K153084 | 000 |
| 10896241002586 | K153084 | 000 |
| 10896241002609 | K153084 | 000 |
| 10896241002579 | K153084 | 000 |
| 10896241002531 | K153084 | 000 |