The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Belmont Fluid Management System (fms2000).
| Device ID | K983975 |
| 510k Number | K983975 |
| Device Name: | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) |
| Classification | Pump, Infusion |
| Applicant | BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Contact | Uraiwan Labadini |
| Correspondent | Uraiwan Labadini BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-09 |
| Decision Date | 1998-11-30 |
| Summary: | summary |