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Dopplex Ultrasonic Doppler System

by Ultramed, Inc.

510(k) K873989

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873989 Date2 Mar 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JOP
Device Class
Class II
Regulation
21 CFR Part 870.2880
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Dopplex Ultrasonic Doppler System is a Class II medical device classified under Transducer, Ultrasonic (Regulation 870.2880), designed for non-invasive assessment of blood flow and vascular conditions. It employs Doppler ultrasound technology to detect and evaluate blood velocity, direction, and turbulence within vessels, aiding in the diagnosis of cardiovascular and peripheral vascular diseases.

This system is intended for use in clinical settings, including hospitals and diagnostic centers, and is supplied as a reusable device. It operates under FDA 510(k) clearance (K873989) with a Substantially Equivalent (SESE) determination, filed under the Cardiovascular advisory committee. Multiple probe configurations are available for varying diagnostic applications, and its regulatory classification aligns with medical specialty designation for cardiovascular use.

Other devices from Ultramed, Inc.