MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES


Device Classification Name

system, ablation, microwave and accessories

510(k) Number K081042
Device Name MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
Applicant
BSD MEDICAL SYSTEMS CORP.
148 s. 1200 e.
salt lake city, 
UT 
84102 -1643

Applicant Contact phil triolo
Correspondent
BSD MEDICAL SYSTEMS CORP.
148 s. 1200 e.
salt lake city, 
UT 
84102 -1643

Correspodent Contact phil triolo
Regulation Number 878.4400
Classification Product Code
NEY  
Date Received 04/11/2008
Decision Date 09/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No