The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Profiler 2.
| Device ID | K063021 |
| 510k Number | K063021 |
| Device Name: | PROFILER 2 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Noel Downey |
| Correspondent | Noel Downey SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2006-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01611740000Z0 | K063021 | 000 |
| B016117081Z0 | K063021 | 000 |
| 05060608880140 | K063021 | 000 |