The following data is part of a premarket notification filed by Scientific Technology Ltd. with the FDA for Fluoroscopic Brightness Stabalizer/fbs Model 9205a.
Device ID | K926064 |
510k Number | K926064 |
Device Name: | FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | SCIENTIFIC TECHNOLOGY LTD. 11845 FORESTGATE DR. Dallas, TX 75243 |
Contact | James R Herrington |
Correspondent | James R Herrington SCIENTIFIC TECHNOLOGY LTD. 11845 FORESTGATE DR. Dallas, TX 75243 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1993-04-27 |