Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOZTECT SENSOR AND BIOZTECT CABLE

K-Number: K011797 · 2001-07-03

ApplicantCardiodynamics International Corp.
Decision Date2001-07-03
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOZTECT SENSOR AND BIOZTECT CABLE 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 2001-07-03 under 510(k) number K011797. 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 BIOZTECT SENSOR AND BIOZTECT CABLE?

BIOZTECT SENSOR AND BIOZTECT CABLE is a medical device that received FDA 510(k) clearance on 2001-07-03. The listed applicant is Cardiodynamics International Corp.. The 510(k) number is K011797.

When did BIOZTECT SENSOR AND BIOZTECT CABLE receive FDA 510(k) clearance?

BIOZTECT SENSOR AND BIOZTECT CABLE received FDA 510(k) clearance on 2001-07-03, under 510(k) number K011797.

Who is the listed applicant for BIOZTECT SENSOR AND BIOZTECT CABLE?

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 BIOZTECT SENSOR AND BIOZTECT CABLE?

The FDA product code for BIOZTECT SENSOR AND BIOZTECT CABLE 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ECGK041294BIOZDX HEMODYNAMIC MONITORK011439MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITORK001081BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

View all 11 devices →

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.

↑