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FDA 510(k)

BIOZDX HEMODYNAMIC MONITOR

K-Number: K041294 · 2004-12-08

ApplicantCardiodynamics International Corp.
Decision Date2004-12-08
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOZDX HEMODYNAMIC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiodynamics International Corp.. It received FDA 510(k) clearance on 2004-12-08 under 510(k) number K041294. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOZDX HEMODYNAMIC MONITOR?

BIOZDX HEMODYNAMIC MONITOR is a medical device that received FDA 510(k) clearance on 2004-12-08. The listed applicant is Cardiodynamics International Corp.. The 510(k) number is K041294.

When did BIOZDX HEMODYNAMIC MONITOR receive FDA 510(k) clearance?

BIOZDX HEMODYNAMIC MONITOR received FDA 510(k) clearance on 2004-12-08, under 510(k) number K041294.

Who is the listed applicant for BIOZDX HEMODYNAMIC MONITOR?

The FDA 510(k) record lists Cardiodynamics International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOZDX HEMODYNAMIC MONITOR?

The FDA product code for BIOZDX HEMODYNAMIC MONITOR is DSB.

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Other records listing Cardiodynamics International Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090602CARDIODYNAMICS BIOZ RX, MODEL 7101-SYSK070156BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100K051228BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECGK011439MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITORK011797BIOZTECT SENSOR AND BIOZTECT CABLEK001081BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

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Related Devices (Code: DSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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