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 | K992672 |
510k Number | K992672 |
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 | 1999-08-10 |
Decision Date | 1999-08-24 |
Summary: | summary |