The following data is part of a premarket notification filed by Health & Life Co., Ltd with the FDA for Full Automatic(nibp) Blood Pressure Monitor.
Device ID | K200521 |
510k Number | K200521 |
Device Name: | Full Automatic(NIBP) Blood Pressure Monitor |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Health & Life Co., Ltd 9F, No. 186 Jian Yi Road, Zhonghe District, New Taipei City, TW 23553 |
Contact | Simon Lee |
Correspondent | Simon Lee Health & Life Co., Ltd 9F, No. 186 Jian Yi Road, Zhonghe District, New Taipei City, TW 23553 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-02 |
Decision Date | 2020-06-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10031262101577 | K200521 | 000 |
10031262101560 | K200521 | 000 |
10031262105025 | K200521 | 000 |
10875011006481 | K200521 | 000 |