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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10010939960181 | K221857 | 000 |
| M3682338A1 | K221857 | 000 |
| M3682338X1 | K221857 | 000 |
| M36823452A1 | K221857 | 000 |
| M36823452C1 | K221857 | 000 |
| M36823452X1 | K221857 | 000 |
| M36823481A1 | K221857 | 000 |
| M36823552N1 | K221857 | 000 |
| M36823552X1 | K221857 | 000 |
| M36823562A1 | K221857 | 000 |
| M36823562C1 | K221857 | 000 |
| M36823562N1 | K221857 | 000 |
| M36823562X1 | K221857 | 000 |
| M36823572A1 | K221857 | 000 |
| M3682360A1 | K221857 | 000 |
| M3682362X2 | K221857 | 000 |
| M3681097002 | K221857 | 000 |