510(k) K141654

THE BELMONT RAPID INFUSER by Belmont Instrument Corporation — Product Code FRN

K141654 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corporation for the device "THE BELMONT RAPID INFUSER". The FDA issued a decision of Substantially Equivalent on July 18, 2014. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Belmont Instrument Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2014
Date Received
June 20, 2014
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