The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Vmx Mobile X-ray System.
Device ID | K910902 |
510k Number | K910902 |
Device Name: | VMX MOBILE X-RAY SYSTEM |
Classification | System, X-ray, Mobile |
Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-05 |
Decision Date | 1991-09-09 |