DM-EMG


Device Classification Name

system, thermal regulating

510(k) Number K072513
Device Name DM-EMG
Applicant
GVP ELETTRONICA SRL
6 durham boat drive
washington crossing, 
PA 
18977

Applicant Contact john romano
Correspondent
GVP ELETTRONICA SRL
6 durham boat drive
washington crossing, 
PA 
18977

Correspodent Contact john romano
Regulation Number 870.5900
Classification Product Code
DWJ  
Date Received 09/06/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No