The following data is part of a premarket notification filed by Guangdong Transtek Medical Electronics Co., Ltd. with the FDA for Blood Pressure Monitor.
| Device ID | K202891 |
| 510k Number | K202891 |
| Device Name: | 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 | Endless Chan |
| 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 | 2020-09-28 |
| Decision Date | 2021-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860004709531 | K202891 | 000 |
| 20860004709507 | K202891 | 000 |
| 00860004709596 | K202891 | 000 |