K950037 is an FDA 510(k) clearance for the N 800 HF. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I - General Controls, product code IZO).
Submitted by Oldelft Corp. of America (Fairfax, US). The FDA issued a Cleared decision on February 15, 1995, 42 days after receiving the submission on January 4, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K950037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 1995 |
| Decision Date | February 15, 1995 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZO — Generator, High-voltage, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1700 |