The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for The Edge Detector, Model 1118.
| Device ID | K051921 |
| 510k Number | K051921 |
| Device Name: | THE EDGE DETECTOR, MODEL 1118 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Noel M Downey |
| Correspondent | Noel M 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 | 2005-07-15 |
| Decision Date | 2005-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01611180001Z0 | K051921 | 000 |
| B01611180000Z0 | K051921 | 000 |
| 05060608880614 | K051921 | 000 |
| 05060608880072 | K051921 | 000 |