The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Edec 60 R/f.
| Device ID | K875341 |
| 510k Number | K875341 |
| Device Name: | EDEC 60 R/F |
| 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 | 1987-12-30 |
| Decision Date | 1988-02-01 |