The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Travel Warmer, Models Tw-400 & Fws-500.
| Device ID | K071263 |
| 510k Number | K071263 |
| Device Name: | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Contact | Norma Lemay |
| Correspondent | Norma Lemay NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-08-24 |
| Summary: | summary |