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FDA 510(k)

CARDIO-MEGA SYSTEM

K-Number: K871890 · 1987-06-12

ApplicantGrandcor Medical Systems
Decision Date1987-06-12
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-MEGA SYSTEM 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 1987-06-12 under 510(k) number K871890. 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-MEGA SYSTEM?

CARDIO-MEGA SYSTEM is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Grandcor Medical Systems. The 510(k) number is K871890.

When did CARDIO-MEGA SYSTEM receive FDA 510(k) clearance?

CARDIO-MEGA SYSTEM received FDA 510(k) clearance on 1987-06-12, under 510(k) number K871890.

Who is the listed applicant for CARDIO-MEGA SYSTEM?

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 CARDIO-MEGA SYSTEM?

The FDA product code for CARDIO-MEGA SYSTEM is DSI.

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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 TESTINGK883410CARDIOMEGA-TK864260APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)K864978APPLISCOPEK864581APPLIDYN

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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.

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