The following data is part of a premarket notification filed by Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. with the FDA for Tenso Ts-101s And Ts-101d Disposable Blood Pressure Cuff.
| Device ID | K153251 |
| 510k Number | K153251 |
| Device Name: | Tenso TS-101S And TS-101D Disposable Blood Pressure Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD. 24/F, 238 ZHONGSHAN EAST ROAD Ningbo, CN 315010 |
| Contact | Charles Shen |
| Correspondent | Charles Shen Manton Business And Technology Services 37 WINDING RIDGE Oakland, NJ 07436 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-10 |
| Decision Date | 2016-04-14 |
| Summary: | summary |