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 Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device.
| Device ID | K161886 |
| 510k Number | K161886 |
| Device Name: | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device |
| 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 | Ada Zhang |
| Correspondent | Ada Zhang GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD ZONE B, No.105, DONGLI ROAD, TORCH DEVELOPMENT DISTRICT Zhongshan, CN 528437 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2016-10-14 |
| Summary: | summary |