Data / Medical devices / China / Shenzhen Pango Medical Electronics Co., Ltd
Shenzhen Pango Medical Electronics Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 10 510(k) clearances
Shenzhen Pango Medical Electronics Co., Ltd is registered with the FDA (registration 3006792041) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006792041
- Address
- No. 25, 1st Industry Zone, Fenghuang Road Xikeng Village, Henggang Town, Longgang District, Shenzhen Guangdong, China, 518115
- Owner or operator
- Shenzhen Pango Medical Electronics Co., Ltd (10037877)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 26, 2011
- Registered through
- 2026
- Brand names listed
- 22-42cm cuff 22-52cm cuff, 22-52cm cuff 22-42cm cuff, ABP801 = PG-800A11, ABP802 = PG-800B11, ANKOVO PG-800B15, Arm Blood Pressure Monitor PG-800B22, Arm Blood Pressure Monitor PG-800B23, Arm Blood Pressure Monitor PG-800B26 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 14, 2023 | K223291 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Pango Medical Electronics Co., Ltd. | accessdata.fda.gov |
| November 10, 2021 | K203746 | Venen-trainer (Model: FM150, SFM90) | JOW | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| December 4, 2020 | K200716 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| April 3, 2019 | K182597 | Infrared thermometer | FLL | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| October 13, 2017 | K170151 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| July 31, 2017 | K161845 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| August 30, 2013 | K131558 | PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 | DXN | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| June 14, 2013 | K131569 | PG-800A SERIES | DXN | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| November 9, 2010 | K102988 | ELECTRONIC BLOOD PRESURE MONITOR | DXN | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| October 15, 2010 | K102920 | ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Orthosis, Lumbar
- All makers of Sleeve, Limb, Compressible
- All makers of Massager, Therapeutic, Electric
- All makers of Hearing Aid, Air-Conduction, Prescription
Updated June 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.