The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for 30kw High Freq. Radio. Gene. Models Hfq-30/hfq30se.
| Device ID | K894479 |
| 510k Number | K894479 |
| Device Name: | 30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
| Contact | Howard Rosenberg |
| Correspondent | Howard Rosenberg BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1989-09-12 |