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FDA 510(k)

ELECTROCARDIOGRAPHIC ECG RECORDER

K-Number: K781152 · 1978-08-31

ApplicantCardio-Dynamics Laboratories, Inc.
Decision Date1978-08-31
Product CodeDSM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPHIC ECG RECORDER 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 1978-08-31 under 510(k) number K781152. The device is classified under product code DSM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROCARDIOGRAPHIC ECG RECORDER?

ELECTROCARDIOGRAPHIC ECG RECORDER is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Cardio-Dynamics Laboratories, Inc.. The 510(k) number is K781152.

When did ELECTROCARDIOGRAPHIC ECG RECORDER receive FDA 510(k) clearance?

ELECTROCARDIOGRAPHIC ECG RECORDER received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781152.

Who is the listed applicant for ELECTROCARDIOGRAPHIC ECG RECORDER?

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 ELECTROCARDIOGRAPHIC ECG RECORDER?

The FDA product code for ELECTROCARDIOGRAPHIC ECG RECORDER is DSM.

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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.

K781911ECG ANALYZER, HIGH SPEEDK781514ECG ELECTRODE, 2021, 2022, 2032, 2033K770988FOAM ECG ELECTRODE, 2060 AND 2061

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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