The following data is part of a premarket notification filed by Guangdong Transtek Medical Electronics Co. Ltd with the FDA for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device.
| Device ID | K181832 |
| 510k Number | K181832 |
| Device Name: | Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Guangdong Transtek Medical Electronics Co. Ltd Zone A, No 105 Dongli Road, Torch Development District Zhongshan, CN 528437 |
| Contact | Nicole Hu |
| Correspondent | Nicole Hu Guangdong Transtek Medical Electronics Co. Ltd Zone A, No 105 Dongli Road, Torch Development District Zhongshan, CN 528437 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2019-04-09 |