The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Edec 2000.
| Device ID | K852908 |
| 510k Number | K852908 |
| Device Name: | EDEC 2000 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | ELECTROMED INTL., LTD. 310,BOULE.INDUSTRIEL ST.-EUSTACHE Quebec, CA J7r 5v3 |
| Contact | Ronald Brault |
| Correspondent | Ronald Brault ELECTROMED INTL., LTD. 310,BOULE.INDUSTRIEL ST.-EUSTACHE Quebec, CA J7r 5v3 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-11-29 |