The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for Quality Reports.
| Device ID | K142142 |
| 510k Number | K142142 |
| Device Name: | QUALITY REPORTS |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORPORATION 2640 NOBILITY AVE. Melbourne, FL 32934 |
| Contact | James Luker |
| Correspondent | James Luker SUN NUCLEAR CORPORATION 2640 NOBILITY AVE. Melbourne, FL 32934 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-05 |
| Decision Date | 2014-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B016121600000 | K142142 | 000 |
| 05060608880874 | K142142 | 000 |