The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Flouroscope, Mobile C-arm Image Intens..
Device ID | K760429 |
510k Number | K760429 |
Device Name: | FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS. |
Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-13 |
Decision Date | 1976-08-23 |