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Litton Datamedix Blood Pressure Monitor Ni

by Litton Datamedix

510(k) K853599

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853599 Date21 Mar 1986ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Litton Datamedix Blood Pressure Monitor Ni is a noninvasive blood pressure measurement system. It provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of transducers placed on the surface of the body.

The device is supplied with FDA 510K authorization and has been found to be substantially equivalent. It is classified as a class 2 device with the product code DXN and K number K853599. The device is used for blood pressure measurement and is a noninvasive system.

Other devices from Litton Datamedix

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Litton Datamedix Blood Pressure Monitor Ni used for?

    The Litton Datamedix Blood Pressure Monitor Ni is used for noninvasive blood pressure measurement, providing systolic, diastolic, mean, or any combination of the three pressures.

  • Is the Litton Datamedix Blood Pressure Monitor Ni supplied sterile?

    The description does not specify if the device is supplied sterile, but it is classified as a noninvasive system.

  • What is the regulatory status of the Litton Datamedix Blood Pressure Monitor Ni?

    The device has been found to be substantially equivalent and is supplied with FDA 510K authorization, classified as a class 2 device with product code DXN.