The following data is part of a premarket notification filed by Odam with the FDA for Minidef (or Defiport.
Device ID | K823933 |
510k Number | K823933 |
Device Name: | MINIDEF (OR DEFIPORT |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | ODAM SIEGE SOCIAL 67160 WISSEMBOURG FRANCE , FR |
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 |