Self Check Digital Blood Press. Monitor

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

510(k) Number

K832171 ↗

FDA Product Code

DXN

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 Ritter Co. →

• What is the SELF CHECK DIGITAL BLOOD PRESS. MONITOR used for?

  It is designed for noninvasive blood pressure measurement in non-clinical or home settings, allowing users to self-monitor systolic, diastolic, mean, or combined pressures using surface-placed transducers.

• How is the SELF CHECK DIGITAL BLOOD PRESS. MONITOR supplied and by whom?

  The device is supplied by Ritter Co. as a self-check digital blood pressure monitor intended for personal use in home environments, not clinical facilities.

• Is the SELF CHECK DIGITAL BLOOD PRESS. MONITOR sterile or single-use?

  The device is noninvasive and uses external transducers placed on the skin, so it does not require sterility; it is designed for repeated use as a reusable home monitoring tool.

• What regulatory pathway was used for the SELF CHECK DIGITAL BLOOD PRESS. MONITOR?

  It received FDA 510(k) clearance under submission K832171, demonstrating substantial equivalence to a legally marketed predicate device, with product code DXN and review by the Cardiovascular advisory committee.