The following data is part of a premarket notification filed by Eureka X-ray Tube Corp. with the FDA for Eureka X-scan 150 X-ray Tube Housing As..
Device ID | K760604 |
510k Number | K760604 |
Device Name: | EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. |
Classification | Assembly, Tube Housing, X-ray, Diagnostic |
Applicant | EUREKA X-RAY TUBE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ITY |
CFR Regulation Number | 892.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-08 |
Decision Date | 1976-09-13 |