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FDA 510(k)

CARDIOCASSETTE II, AMBULATORY ECG SYSTEM

K-Number: K790509 · 1979-03-23

ApplicantCambridge Instruments, Inc.
Decision Date1979-03-23
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCASSETTE II, AMBULATORY ECG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Instruments, Inc.. It received FDA 510(k) clearance on 1979-03-23 under 510(k) number K790509. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCASSETTE II, AMBULATORY ECG SYSTEM?

CARDIOCASSETTE II, AMBULATORY ECG SYSTEM is a medical device that received FDA 510(k) clearance on 1979-03-23. The listed applicant is Cambridge Instruments, Inc.. The 510(k) number is K790509.

When did CARDIOCASSETTE II, AMBULATORY ECG SYSTEM receive FDA 510(k) clearance?

CARDIOCASSETTE II, AMBULATORY ECG SYSTEM received FDA 510(k) clearance on 1979-03-23, under 510(k) number K790509.

Who is the listed applicant for CARDIOCASSETTE II, AMBULATORY ECG SYSTEM?

The FDA 510(k) record lists Cambridge Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOCASSETTE II, AMBULATORY ECG SYSTEM?

The FDA product code for CARDIOCASSETTE II, AMBULATORY ECG SYSTEM is DSH.

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Other records listing Cambridge Instruments, 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.

K811121CENTRAL STATION MONITORING SYSTEMSK811062CAMPBRIDGE COMPUTRACEK8032294-CHANNEL ECG TELEMETRY MON. SYST. #3045K801224CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEMK800566CAMBRIDGE VS-550 ELECTROCARDIOGRAPHK792661TREADMILL MODEL 3060

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Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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