Electronic Blood Pressure Monitor

59 catalogue numbers from PG-800B42, listed by Shenzhen Pango Electronic Co., Ltd., China, under System, Measurement, Blood-Pressure, Non-Invasive. 98 manufacturers in China are registered for this product code.

Registry build 21.09.26
98manufacturers in China registered for this device type
59catalogue numbers in this listing
7510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code DXN
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

Regulatory record for Electronic Blood Pressure Monitor
Listed by Shenzhen Pango Electronic Co., Ltd., China
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
510(k) K131569
Record published 2018-07-06
Record revised 2019-11-08 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Electronic Blood Pressure Monitor
Catalogue number Size Status
PG-800B42 In distribution
PG-800AD-1 In distribution
PG-800B6D In distribution
PG-800A3 In distribution
PG-800A15 In distribution
PG-800A32 In distribution
PG-800B15 In distribution
PG-800B6-2 In distribution
PG-800B5-1 In distribution
PG-800A9 In distribution
PG-800A36 In distribution
PG-800A6-1 In distribution
PG-800A12 In distribution
PG-800B12 In distribution
PG-800B5 In distribution
PG-800B11 In distribution
PG-800A27 In distribution
PG-800A6D In distribution
PG-800B4D In distribution
PG-800B26 In distribution
PG-800B10 In distribution
PG-800AD In distribution
PG-800B36 In distribution
PG-800A25 In distribution
PG-800B32 In distribution
PG-800A In distribution
PG-800B6 In distribution
PG-800A31 In distribution
PG-800B4 In distribution
PG-800BD-1 In distribution
PG-800A4D In distribution
PG-800B7 In distribution
PG-800A4 In distribution
PG-800A6-2 In distribution
PG-800B In distribution
PG-800A11 In distribution
PG-800A7D In distribution
PG-800B27 In distribution
PG-800B6-1 In distribution
PG-800A37 In distribution
PG-800A-1 In distribution
PG-800B35 In distribution
PG-800B3 In distribution
PG-800B37 In distribution
PG-800B31 In distribution
PG-800B43 In distribution
PG-800B23 In distribution
PG-800A8 In distribution
PG-800A35 In distribution
PG-800A7 In distribution
PG-800A6 In distribution
PG-800B8 In distribution
PG-800B33 In distribution
PG-800B22 In distribution
PG-800A33 In distribution
PG-800B9 In distribution
PG-800B-1 In distribution
PG-800BD In distribution
PG-800A5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Baum W.A. Baum Co., Inc. 116
Alphamed Shenzhen Urion Technology Co., Ltd. 68
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
System, Measurement, Blood-Pressure, Non-Invasive Shenzhen Urion Technology Co., Ltd. 44

Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K200716 2020-12-04
K170151 2017-10-13
K161845 2017-07-31
K131558 2013-08-30
K131569 2013-06-14
K102988 2010-11-09
K102920 2010-10-15

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer