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 |