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Tebco (Thoracic Electrical Bioimpedance Cardiac Output)

by Hemo Sapiens, Inc.

510(k) K962128

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 NumberK962128 Date21 Nov 1996ClearedStatusActive

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  • Withdrawn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
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Tebco (Thoracic Electrical Bioimpedance Cardiac Output) is a computer-based diagnostic device that measures cardiodynamic parameters, including cardiac index, heart rate, and stroke index. It is a pre-programmed, single-function device classified as Class II with special controls. The device provides continuous and non-invasive measurements of various cardiac parameters.

The Tebco device is supplied with FDA 510(k) clearance and is regulated under product code DXG. It is intended for use in a cardiovascular setting and is manufactured by Hemo Sapiens, Inc. The device has a registration number and is subject to regulation under 870.1435. The clearance was granted on November 21, 1996, with the k number K962128.

Other devices from Hemo Sapiens, Inc.

  • Hotman

    Class II

Questions

AI-generated answers, 22 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 Tebco device used for?

    The Tebco device is used to measure cardiodynamic parameters, including cardiac index, heart rate, and stroke index, in a cardiovascular setting.

  • Is the Tebco device invasive or non-invasive?

    The Tebco device provides non-invasive measurements of various cardiac parameters.

  • What is the regulatory status of the Tebco device?

    The Tebco device has been granted FDA 510(k) clearance and is regulated under product code DXG.

  • What type of device is the Tebco?

    The Tebco is a computer-based diagnostic device, classified as Class II with special controls.