The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for N 800 Hf.
| Device ID | K953831 |
| 510k Number | K953831 |
| Device Name: | N 800 HF |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | NUCLETRON-OLDELFT CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2119 |
| Contact | Stephen P Teague |
| Correspondent | Stephen P Teague NUCLETRON-OLDELFT CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2119 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1995-09-08 |