The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Defibrillator 7501.
| Device ID | K854307 |
| 510k Number | K854307 |
| Device Name: | KONTRON DEFIBRILLATOR 7501 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | George Cho |
| Correspondent | George Cho KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-25 |
| Decision Date | 1985-12-04 |