510(k) K091855

THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 by Belmont Instrument Corp. — Product Code FRN

K091855 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corp. for the device "THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000". The FDA issued a decision of Substantially Equivalent on July 1, 2009. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Belmont Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2009
Date Received
June 23, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type