EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC


Device Classification Name

dc-defibrillator, low-energy, (including paddles)

510(k) Number K103783
Device Name EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
Applicant
FIAB S.P.A.
via costoli, 4
vicchio florence, 

IT

50039

Applicant Contact alberto calabro
Correspondent
FIAB S.P.A.
via costoli, 4
vicchio florence, 

IT

50039

Correspodent Contact alberto calabro
Regulation Number 870.5300
Classification Product Code
LDD  
Date Received 12/27/2010
Decision Date 06/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No