Bioland
The Bioland blood pressure monitor filing includes model 2006-2. It identifies the device as a noninvasive blood-pressure measurement system. The monitor measures blood pressure and pulse…
The Bioland blood pressure monitor filing includes model 2006-2. It identifies the device as a noninvasive blood-pressure measurement system.
The monitor measures blood pressure and pulse rate in adults, and the filing notes that it detects irregular heartbeats during measurement.
Role and Configuration
The described monitor includes a cuff, air tube, display, controls, shell and battery. Cuff pressure is read through a transducer using an oscillometric method.
The source describes systolic and diastolic pressure and pulse information as transmitted through cuff air pressure for determination.
Who Else Makes It
Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Dongguan Polygreen Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Brav Electronic Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive
Record
| Listed by | Bioland Technology Ltd., China |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| Establishment | Manufacturer |
| 510(k) | K201467 |
| Record published | 2020-11-16 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 10, pack of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2006-2 | In distribution | |
| 2005 | In distribution | |
| A221-2 | In distribution | |
| 2008 | In distribution | |
| 2006 | In distribution | |
| 2006-2B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Baum | W.A. Baum Co., Inc. | 116 |
| Alphamed | Shenzhen Urion Technology Co., Ltd. | 68 |
| Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 59 |
| Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd. | 58 |
| A&D Medical | A&D Company, Ltd. | 56 |
| Diagnostix™ | American Diagnostic Corp. | 54 |
| Lutech | Lutech Industries | 51 |
| Veridian | Veridian Healthcare | 50 |
| Hopkins Medical Products® | Hopkins Uniform Company | 49 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 49 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 48 |
| SunTech | Suntech Medical, Inc. | 46 |
Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202934 | 2021-01-26 |
| K201467 | 2020-09-21 |
| K083681 | 2009-01-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.