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 |