The following data is part of a premarket notification filed by Euro-electronics, Inc. with the FDA for Exposcop Mobile Imaging System.
| Device ID | K851031 |
| 510k Number | K851031 |
| Device Name: | EXPOSCOP MOBILE IMAGING SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | EURO-ELECTRONICS, INC. 16494 NE 27TH. PLACE Miami, FL 33160 |
| Contact | Kenneth J Finck |
| Correspondent | Kenneth J Finck EURO-ELECTRONICS, INC. 16494 NE 27TH. PLACE Miami, FL 33160 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-05-28 |