510(k) K992672

BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) by Belmont Instrument Corp. — Product Code FRN

K992672 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corp. for the device "BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)". The FDA issued a decision of Substantially Equivalent on August 24, 1999. 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
August 24, 1999
Date Received
August 10, 1999
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