The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Mobil Xr.
Device ID | K781705 |
510k Number | K781705 |
Device Name: | MOBIL XR |
Classification | System, X-ray, Mobile |
Applicant | SIEMENS CORP. 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 | 1978-10-10 |
Decision Date | 1978-10-24 |