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BioZDx Hemodynamic Monitor

by Cardiodynamics International Corp.

510(k) K041294

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 NumberK041294 Date8 Dec 2004ClearedStatusActive

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  • Withdrawn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
DSB
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 BioZDx Hemodynamic Monitor is an impedance plethysmograph designed for cardiovascular monitoring. It functions by measuring impedance changes to provide hemodynamic data for clinical assessment.

This device is manufactured by Cardiodynamics International Corp. and is authorized under FDA 510(k) number K041294. It is classified as a Class 2 medical device under regulation number 870.2770.

Other devices from Cardiodynamics International Corp.

See all devices from Cardiodynamics International Corp. →

Questions

AI-generated answers, 24 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 primary function of the BioZDx Hemodynamic Monitor?

    The BioZDx is an impedance plethysmograph designed for cardiovascular monitoring. It operates by measuring impedance changes within the body to provide hemodynamic data, which assists clinicians in performing cardiovascular assessments.

  • What is the regulatory status of this device?

    The BioZDx Hemodynamic Monitor is authorized under FDA 510(k) number K041294. It is classified as a Class 2 medical device under regulation number 870.2770.

  • Who is the manufacturer of the BioZDx Hemodynamic Monitor?

    This device is manufactured by Cardiodynamics International Corp., located in San Diego, California.