The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Fluoroscopic Automatic Brightness Cntl.
| Device ID | K843917 |
| 510k Number | K843917 |
| Device Name: | FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | AFP IMAGING CORP. 9410 M DESOTO AVENUE Chatsworth , CA 91311 - |
| Contact | Robert E Johnson |
| Correspondent | Robert E Johnson AFP IMAGING CORP. 9410 M DESOTO AVENUE Chatsworth , CA 91311 - |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-05 |
| Decision Date | 1985-01-03 |