COMPACT-X
Generator, High-voltage, X-ray, Diagnostic
ELECTROMED INTL., LTD.
The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Compact-x.
Pre-market Notification Details
| Device ID | K950694 |
| 510k Number | K950694 |
| Device Name: | COMPACT-X |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-14 |
| Decision Date | 1995-03-31 |
Trademark Results [COMPACT-X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMPACT-X 76218597 2648480 Dead/Cancelled |
Electromed International Limitee 2001-02-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.