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)

CARDIO EXPRESS 100 HOLTER SCANNER

K-Number: K840622 · 1984-07-02

ApplicantDel Mar Avionics
Decision Date1984-07-02
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO EXPRESS 100 HOLTER SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1984-07-02 under 510(k) number K840622. 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 CARDIO EXPRESS 100 HOLTER SCANNER?

CARDIO EXPRESS 100 HOLTER SCANNER is a medical device that received FDA 510(k) clearance on 1984-07-02. The listed applicant is Del Mar Avionics. The 510(k) number is K840622.

When did CARDIO EXPRESS 100 HOLTER SCANNER receive FDA 510(k) clearance?

CARDIO EXPRESS 100 HOLTER SCANNER received FDA 510(k) clearance on 1984-07-02, under 510(k) number K840622.

Who is the listed applicant for CARDIO EXPRESS 100 HOLTER SCANNER?

The FDA 510(k) record lists Del Mar Avionics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO EXPRESS 100 HOLTER SCANNER?

The FDA product code for CARDIO EXPRESS 100 HOLTER SCANNER 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 Del Mar Avionics 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.

K990027OMNICORDER, MODEL 464K971696SENTINEL RECORDER, MODELS 471/472K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)K950020HOLTER PACERCORDER(R)K942653HOLTER SSR DIGICORDER(TM)K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

View all 54 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.

↑