The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Comfortmate Fluid Warming System, Model # Fw-200; Comfortmate Disporsable Disposable Warming Set, Model #fws-200.
| Device ID | K012832 |
| 510k Number | K012832 |
| Device Name: | COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Contact | Karen St. Onge |
| Correspondent | Karen St. Onge NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-23 |
| Decision Date | 2001-10-24 |
| Summary: | summary |