The following data is part of a premarket notification filed by Odam with the FDA for Defigard 2000.
| Device ID | K854175 |
| 510k Number | K854175 |
| Device Name: | DEFIGARD 2000 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ODAM 19, AVENUE DE LA GARE B.P. 50 WISSEMBOURG CEDEX, FR 67162 |
| Contact | CANSELL |
| Correspondent | CANSELL ODAM 19, AVENUE DE LA GARE B.P. 50 WISSEMBOURG CEDEX, FR 67162 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1986-01-13 |