Rossmax Smartinflate Cardiopro, Model 1000I and Model 3000I Blood Pressure Monitors

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

510(k) Number

K011352 ↗

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

• Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Rm-4100

  Class II

  FDA 510(k) K992387 Active Cleared 3 Aug 1999

• Rossmax Automatic Wristwatch Blood Pressure Monitor, Model V46

  Class II

  FDA 510(k) K993542 Active Cleared 29 Dec 1999

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

  Class II

  FDA 510(k) K052727 Active Cleared 16 Dec 2005

• Rossmax Automatic Wristwatch Blood Pressure Monitor, Model BPW138

  Class II

  FDA 510(k) K011523 Active Cleared 14 Jun 2001

• Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Z46

  Class II

  FDA 510(k) K993432 Active Cleared 20 Dec 1999

• Rossmax Medipro Model 10 and 60, Medicare Model 10 and 60 Blood Pressure Monitors

  Class II

  FDA 510(k) K013583 Active Cleared 17 Jan 2002

See all devices from Rossmax International, Ltd. →