The following data is part of a premarket notification filed by General Medical Merate S.p.a. with the FDA for X-ray Generating System Tf 1000.
| Device ID | K881386 |
| 510k Number | K881386 |
| Device Name: | X-RAY GENERATING SYSTEM TF 1000 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | GENERAL MEDICAL MERATE S.P.A. 23-06 31ST AVE. Long Island City, NY 11106 |
| Contact | George Pavel |
| Correspondent | George Pavel GENERAL MEDICAL MERATE S.P.A. 23-06 31ST AVE. Long Island City, NY 11106 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-07-08 |