The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for X-ray, Portable.
Device ID | K781276 |
510k Number | K781276 |
Device Name: | X-RAY, PORTABLE |
Classification | System, X-ray, Mobile |
Applicant | AIR-SHIELDS, 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 | 1978-07-24 |
Decision Date | 1978-08-10 |