The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Cd-r Station And Vrs-2000.
| Device ID | K974255 |
| 510k Number | K974255 |
| Device Name: | CD-R STATION AND VRS-2000 |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | ELECTROMED INTL., LTD. 310 INDUSTRIAL BLVD. St-eustache, Quebec, CA J7r 5r4 |
| Contact | James Riedl |
| Correspondent | James Riedl ELECTROMED INTL., LTD. 310 INDUSTRIAL BLVD. St-eustache, Quebec, CA J7r 5r4 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-13 |
| Decision Date | 1998-01-27 |
| Summary: | summary |