The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Edec 50c Constant Potential X-ray Generator.
| Device ID | K871145 |
| 510k Number | K871145 |
| Device Name: | EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | ELECTROMED INTL., LTD. 395 BOUL. INDUSTRIEL ST-EUSTACHE, QUEBEC Canada, CA J7r 5r3 |
| Contact | Ramirez, Eng |
| Correspondent | Ramirez, Eng ELECTROMED INTL., LTD. 395 BOUL. INDUSTRIEL ST-EUSTACHE, QUEBEC Canada, CA J7r 5r3 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-23 |
| Decision Date | 1987-03-31 |