The following data is part of a premarket notification filed by Odam with the FDA for Defigard M(or Defiscope M.
| Device ID | K823931 |
| 510k Number | K823931 |
| Device Name: | DEFIGARD M(OR DEFISCOPE M |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ODAM 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-29 |
| Decision Date | 1983-04-12 |