The following data is part of a premarket notification filed by Carina Medical Llc with the FDA for Intdose.
| Device ID | K213137 |
| 510k Number | K213137 |
| Device Name: | INTDose |
| Classification | Accelerator, Linear, Medical |
| Applicant | Carina Medical LLC 1233 Litchfield Ln Lexington, KY 40513 |
| Contact | Xue Feng |
| Correspondent | Xue Feng Carina Medical LLC 1233 Litchfield Ln Lexington, KY 40513 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2022-05-13 |