The following data is part of a premarket notification filed by Klarity Medical & Equipment (gz) Co., Ltd. with the FDA for Klarity Bolus.
| Device ID | K202747 |
| 510k Number | K202747 |
| Device Name: | Klarity Bolus |
| Classification | Accelerator, Linear, Medical |
| Applicant | Klarity Medical & Equipment (GZ) Co., Ltd. No. 14 3rd St., Shawan GETDD Guangzhou, CN 510730 |
| Contact | Lucy Li |
| Correspondent | Peter Larson Klarity Medical Products, LLC 600 Industrial Parkway Heath, OH 43056 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-05-14 |