The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Heatfx Microwave Ablation System, Heatfx Microwave Ablation System Cart, Heatfx 2.1 Needle, Heatfx 2.1 S Needle, Multi-point Thermal Sensor (mts).
|Device Name:||HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)|
|Classification||System, Ablation, Microwave And Accessories|
|Applicant||Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112|
Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112
|CFR Regulation Number||878.4400 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|