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FDA 510(k)

ECG ANALYZER, HIGH SPEED

K-Number: K781911 · 1978-11-30

ApplicantCardio-Dynamics Laboratories, Inc.
Decision Date1978-11-30
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG ANALYZER, HIGH SPEED is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Dynamics Laboratories, Inc.. It received FDA 510(k) clearance on 1978-11-30 under 510(k) number K781911. 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 ECG ANALYZER, HIGH SPEED?

ECG ANALYZER, HIGH SPEED is a medical device that received FDA 510(k) clearance on 1978-11-30. The listed applicant is Cardio-Dynamics Laboratories, Inc.. The 510(k) number is K781911.

When did ECG ANALYZER, HIGH SPEED receive FDA 510(k) clearance?

ECG ANALYZER, HIGH SPEED received FDA 510(k) clearance on 1978-11-30, under 510(k) number K781911.

Who is the listed applicant for ECG ANALYZER, HIGH SPEED?

The FDA 510(k) record lists Cardio-Dynamics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG ANALYZER, HIGH SPEED?

The FDA product code for ECG ANALYZER, HIGH SPEED is DSI.

Related Clinical Trials

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Other records listing Cardio-Dynamics Laboratories, Inc. 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.

K781514ECG ELECTRODE, 2021, 2022, 2032, 2033K781152ELECTROCARDIOGRAPHIC ECG RECORDERK770988FOAM ECG ELECTRODE, 2060 AND 2061

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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