The following data is part of a premarket notification filed by Fiab S.p.a. with the FDA for Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric.
| Device ID | K103783 |
| 510k Number | K103783 |
| Device Name: | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | FIAB S.P.A. VIA COSTOLI, 4 Vicchio Florence, IT 50039 |
| Contact | Alberto Calabro |
| Correspondent | Alberto Calabro FIAB S.P.A. VIA COSTOLI, 4 Vicchio Florence, IT 50039 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-06-16 |
| Summary: | summary |