The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Defi 2.
| Device ID | K851931 |
| 510k Number | K851931 |
| Device Name: | DEFI 2 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | S & W MEDICO TEKNIK 1819 H. ST. NW FEDERAL BAR BLDG. Washington, DC 20006 |
| Contact | Jes Petersen |
| Correspondent | Jes Petersen S & W MEDICO TEKNIK 1819 H. ST. NW FEDERAL BAR BLDG. Washington, DC 20006 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-02 |
| Decision Date | 1985-08-05 |