The following data is part of a premarket notification filed by Guangdong Transtek Medical Electronics Co., Ltd. with the FDA for Transtek Wrist Blood Pressure Monitor.
| Device ID | K202599 |
| 510k Number | K202599 |
| Device Name: | Transtek Wrist Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District Zhongshan, CN 528437 |
| Contact | Nicole Hu |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, CN 518067 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2020-12-06 |