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)

CARDIOMEGA-T

K-Number: K883410 · 1988-10-17

ApplicantGrandcor Medical Systems
Decision Date1988-10-17
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMEGA-T is the device name listed in this FDA 510(k) record. The listed applicant is Grandcor Medical Systems. It received FDA 510(k) clearance on 1988-10-17 under 510(k) number K883410. 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 CARDIOMEGA-T?

CARDIOMEGA-T is a medical device that received FDA 510(k) clearance on 1988-10-17. The listed applicant is Grandcor Medical Systems. The 510(k) number is K883410.

When did CARDIOMEGA-T receive FDA 510(k) clearance?

CARDIOMEGA-T received FDA 510(k) clearance on 1988-10-17, under 510(k) number K883410.

Who is the listed applicant for CARDIOMEGA-T?

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

What is the FDA product code for CARDIOMEGA-T?

The FDA product code for CARDIOMEGA-T 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 Grandcor Medical Systems 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.

K905480SPIROSCOPEK895547GRANDCOR/CARDIOLINE ECT STRESS TESTINGK871890CARDIO-MEGA SYSTEMK864260APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)K864978APPLISCOPEK864581APPLIDYN

View all 8 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.

↑