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 |