The following data is part of a premarket notification filed by General X-ray, Inc. with the FDA for Portable X-ray Unit.
Device ID | K790512 |
510k Number | K790512 |
Device Name: | PORTABLE X-RAY UNIT |
Classification | System, X-ray, Mobile |
Applicant | GENERAL X-RAY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-16 |
Decision Date | 1979-03-26 |