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FDA 510(k)

BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG

K-Number: K051228 · 2005-06-10

ApplicantCardiodynamics International Corp.
Decision Date2005-06-10
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG 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 2005-06-10 under 510(k) number K051228. 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 AND 12-LEAD ECG?

BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG is a medical device that received FDA 510(k) clearance on 2005-06-10. The listed applicant is Cardiodynamics International Corp.. The 510(k) number is K051228.

When did BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG receive FDA 510(k) clearance?

BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG received FDA 510(k) clearance on 2005-06-10, under 510(k) number K051228.

Who is the listed applicant for BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG?

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 AND 12-LEAD ECG?

The FDA product code for BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG 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 5100K041294BIOZDX HEMODYNAMIC MONITORK011439MODIFICATION 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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