THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000

Pump, Infusion

BELMONT INSTRUMENT CORP.

The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for The Belmont Fluid Management System/ The Belmont Rapid Infuser, Model Fms2000.

Pre-market Notification Details

• Device ID: K091855
• 510k Number: K091855
• Device Name: THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL 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: 2009-06-23
• Decision Date: 2009-07-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
80896128002370	K091855	000
00896128002565	K091855	000
00896128002558	K091855	000
00896128002428	K091855	000
00896128002411	K091855	000
00896128002404	K091855	000
00896128002398	K091855	000
00896128002381	K091855	000
00896128002367	K091855	000
00896128002350	K091855	000
00896128002343	K091855	000
00896128002329	K091855	000
00896128002305	K091855	000
00896128002602	K091855	000
00896128002619	K091855	000
10896128002036	K091855	000
80896128002035	K091855	000
70896128002373	K091855	000
70896128002038	K091855	000
60896128002376	K091855	000
60896128002031	K091855	000
50896128002379	K091855	000
50896128002034	K091855	000
40896128002372	K091855	000
40896128002037	K091855	000
30896128002375	K091855	000
20896128002378	K091855	000
20896128002033	K091855	000
00896128002336	K091855	000