The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Blood Pressure Monitor-model 2005, 2006-2, 2006-2b.
| Device ID | K201467 |
| 510k Number | K201467 |
| Device Name: | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, CN 518116 |
| Contact | Yiqing Feng |
| Correspondent | Yiqing Feng Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, CN 518116 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-02 |
| Decision Date | 2020-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939184626079 | K201467 | 000 |