The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Nibp Cuff.
| Device ID | K193629 |
| 510k Number | K193629 |
| Device Name: | Disposable NIBP Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | Shenzhen Changke Connect Electronics Co., Ltd. A2-4th Floor Of Xiang Dali Technology Park No.87 Of HengPing Road, Henggang Longgang District, Shenzhen, CN 518000 |
| Contact | Yahui Zhou |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-03-25 |