The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Model 1133 Ivd Pc Version.
| Device ID | K021463 |
| 510k Number | K021463 |
| Device Name: | MODEL 1133 IVD PC VERSION |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Jim Mixon |
| Correspondent | Jim Mixon SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-07 |
| Decision Date | 2002-06-06 |
| Summary: | summary |