K843443 is an FDA 510(k) clearance for the EDEC-100. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I - General Controls, product code IZO).
Submitted by Electromed Intl., Ltd. (Willoughby, US). The FDA issued a Cleared decision on March 1, 1985, 178 days after receiving the submission on September 4, 1984.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K843443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1984 |
| Decision Date | March 01, 1985 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZO — Generator, High-voltage, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1700 |