FDA 510(k)

BIOZ SYSTEM

K-Number: K963183 · 1996-11-26

ApplicantCardiodynamics International Corp.

Decision Date1996-11-26

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIOZ SYSTEM 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 1996-11-26 under 510(k) number K963183. 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 BIOZ SYSTEM?

BIOZ SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-26. The listed applicant is Cardiodynamics International Corp.. The 510(k) number is K963183.

When did BIOZ SYSTEM receive FDA 510(k) clearance?

BIOZ SYSTEM received FDA 510(k) clearance on 1996-11-26, under 510(k) number K963183.

Who is the listed applicant for BIOZ SYSTEM?

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 BIOZ SYSTEM?

The FDA product code for BIOZ SYSTEM is DSB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardiodynamics International Corp. as applicant

K090602CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS K070156BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 K051228BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG K041294BIOZDX HEMODYNAMIC MONITOR K011439MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR K011797BIOZTECT SENSOR AND BIOZTECT CABLE

View all 11 devices →

Related Devices (Code: DSB)

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC K243727Re:BalansMode Sensors AS K250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed Limited K223217Zynex 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.