EP 3000
System, X-ray, Fluoroscopic, Image-intensified
OEC-DIASONICS, INC.
The following data is part of a premarket notification filed by Oec-diasonics, Inc. with the FDA for Ep 3000.
Pre-market Notification Details
| Device ID | K924879 |
| 510k Number | K924879 |
| Device Name: | EP 3000 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | OEC-DIASONICS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Jeffdrey W Wagner |
| Correspondent | Jeffdrey W Wagner OEC-DIASONICS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-28 |
| Decision Date | 1993-01-04 |
Trademark Results [EP 3000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EP 3000 74462490 not registered Dead/Abandoned |
OEC MEDICAL SYSTEMS, INC. 1993-11-23 |
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