510(k) K152208

The Belmont Hyperthermia Pump by Belmont Instrument Corporation — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2015
Date Received
August 7, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type