The following data is part of a premarket notification filed by Oldelft Corp. Of America with the FDA for N 800 Hf.
| Device ID | K950037 |
| 510k Number | K950037 |
| Device Name: | N 800 HF |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Contact | Charles Pattie |
| Correspondent | Charles Pattie OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-04 |
| Decision Date | 1995-02-15 |