The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Edec-100.
| Device ID | K843443 |
| 510k Number | K843443 |
| Device Name: | EDEC-100 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | ELECTROMED INTL., LTD. 38201 EAST SPAULDING STREET CLAIR BLDG. Willoughby , OH 44094 - |
| Contact | Bruce G Lacasse |
| Correspondent | Bruce G Lacasse ELECTROMED INTL., LTD. 38201 EAST SPAULDING STREET CLAIR BLDG. Willoughby , OH 44094 - |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-04 |
| Decision Date | 1985-03-01 |