The following data is part of a premarket notification filed by Zhejiang Lude Technology Development Co., Ltd. with the FDA for Aneroid Sphygmomanometer With Stethoscope, Ql-50, Aneroid Sphygmomanometer, Ql-20, Aneroid Sphygmomanometer, Ql-201.
| Device ID | K221857 |
| 510k Number | K221857 |
| Device Name: | Aneroid Sphygmomanometer With Stethoscope, QL-50, Aneroid Sphygmomanometer, QL-20, Aneroid Sphygmomanometer, QL-201 |
| Classification | Blood Pressure Cuff |
| Applicant | Zhejiang LuDe Technology Development Co., Ltd. NO. 298 Jichang North Road, Longwan District Wenzhou, CN 325024 |
| Contact | Iris Du |
| Correspondent | Iris Du Zhejiang LuDe Technology Development Co., Ltd. NO. 298 Jichang North Road, Longwan District Wenzhou, CN 325024 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-10-13 |