Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K240729 ↗

FDA Product Code

DXN

FDA applicant

Shenzhen Pango Medical Electronics Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Automatyczny cisnieniomierz stacjonarny

  Class IIa

  CE/MDR 28620184373-02 Active Valid to Jul 2029

• Termometr bezdotykowy

  Class IIa

  CE/MDR 28620184373-02 Active Valid to Jul 2029

• Infrared Forehead Thermometer

  Class IIa

  CE/MDR 28620184373-02 Active Valid to Jul 2029 GUDID on market

• Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618

  Class II

  FDA 510(k) K212346 Active Cleared 5 May 2022

• Blood pressure monitor

  Class IIa

  CE/MDR 28620184373-02 Active Valid to Jul 2029

• Electronic Blood Pressure Monitor

  Class IIa

  CE/MDR 28620184373-02 Active Valid to Jul 2029 FDA 510(k) ×7 K200716 Active

See all devices from Shenzhen Pango Medical Electronics Co., Ltd →

• Are these monitors intended for single-use or reusable in clinical settings, and what does that mean for maintenance?

  These electronic blood pressure monitors (models PG-800B30 through PG-800B61) are reusable electronic devices designed for clinical use in hospitals, outpatient clinics, and home healthcare. Since they are not sterile, they require regular calibration and maintenance as outlined by the manufacturer to ensure accuracy and reliability. Proper cleaning and adherence to the manufacturer’s guidelines are essential to sustain performance over repeated use.

• What types of environments are these monitors approved for, and how should they be stored?

  These monitors are authorized for use in clinical settings, including hospitals, outpatient clinics, and home healthcare environments. Storage must follow the manufacturer’s instructions to preserve accuracy and longevity. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, typical guidelines for electronic medical devices—like avoiding extreme temperatures or direct sunlight—likely apply. Always refer to the manufacturer’s documentation for precise storage protocols.

• How do I know which model is right for my facility, and do they differ in any way?

  The listed models (PG-800B30 through PG-800B61) are all automated non-invasive sphygmomanometers using oscillometric technology, meaning they measure blood pressure via an upper-arm cuff. While the exact differences between models aren’t specified in the data, they may vary in features like display size, memory capacity, or additional functions (e.g., heart rate monitoring). Contact the manufacturer or check their product documentation to confirm which model aligns with your facility’s needs, such as patient volume or specific clinical workflows.

• What regulatory pathways have these monitors gone through, and what does that mean for purchasing?

  These monitors have undergone FDA 510(k) clearance and MDR compliance, with all models listed under product code DXN. The FDA’s 510(k) process confirms they meet safety and performance standards comparable to existing devices, while MDR compliance ensures they align with European Union regulations. For purchasing, this means they meet stringent regulatory requirements for clinical use in the U.S. and EU markets, though you should verify local compliance needs for your specific region.