The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Evaluskop.
| Device ID | K781711 |
| 510k Number | K781711 |
| Device Name: | EVALUSKOP |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-05 |
| Decision Date | 1978-10-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EVALUSKOP 73165902 1122738 Dead/Expired |
SIEMENS AKTIENGESELLSCHAFT 1978-04-11 |