The following data is part of a premarket notification filed by Dynarad Corp. with the FDA for Control, X-ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic, Beam Limiting Device, Manual.
| Device ID | K973833 |
| 510k Number | K973833 |
| Device Name: | CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL |
| Classification | System, X-ray, Mobile |
| Applicant | DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
| Contact | Raymond Manez |
| Correspondent | Raymond Manez DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1997-12-30 |