The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Belmont Fluid Management System, Model Fms2000.
| Device ID | K032674 |
| 510k Number | K032674 |
| Device Name: | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Contact | Uraiwan P Labadini |
| Correspondent | Uraiwan P Labadini BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-29 |
| Decision Date | 2003-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20896128002019 | K032674 | 000 |
| 10896128002012 | K032674 | 000 |