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)

ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW

K-Number: K984089 · 1999-02-16

ApplicantZymed Medical Instrumentation
Decision Date1999-02-16
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW is the device name listed in this FDA 510(k) record. The listed applicant is Zymed Medical Instrumentation. It received FDA 510(k) clearance on 1999-02-16 under 510(k) number K984089. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW?

ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW is a medical device that received FDA 510(k) clearance on 1999-02-16. The listed applicant is Zymed Medical Instrumentation. The 510(k) number is K984089.

When did ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW receive FDA 510(k) clearance?

ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW received FDA 510(k) clearance on 1999-02-16, under 510(k) number K984089.

Who is the listed applicant for ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW?

The FDA 510(k) record lists Zymed Medical Instrumentation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW?

The FDA product code for ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW is DSI.

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 Zymed Medical Instrumentation 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.

K002004ZYBITK992197MODIFICATION TO ZYMED HOLTER 2000K990170HOLTER 2000K955015ZYMED HOLTER SCANNER MODEL 2010K951370ZYMED TELEMETRY SYSTEM; MODEL T8010K930894MULTITRAK-PLUS

View all 7 devices →

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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.

↑