Rossmax Non-Invasive Blood Pressure Monitors, Models S380, K350

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

510(k) Number

K052727 ↗

FDA Product Code

DXN

FDA applicant

Rossmax International , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Rossmax International, Ltd. →

• What is the intended use of the Rossmax Non-Invasive Blood Pressure Monitors?

  The monitors are intended for self-monitoring of blood pressure in adult patients at home.

• How do the Rossmax Blood Pressure Monitors operate?

  They operate through cuff inflation and deflation, and automated signal processing of pressure oscillations to determine blood pressure values.

• What is the product code for the Rossmax Non-Invasive Blood Pressure Monitors?

  The product code is DXN, classified as non-invasive blood pressure measurement systems.