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FDA 510(k)

CARDIO TEHCHANALYZER

K-Number: K821711 · 1982-10-04

ApplicantCardio Technology , Ltd.
Decision Date1982-10-04
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO TEHCHANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Technology , Ltd.. It received FDA 510(k) clearance on 1982-10-04 under 510(k) number K821711. 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 TEHCHANALYZER?

CARDIO TEHCHANALYZER is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is Cardio Technology , Ltd.. The 510(k) number is K821711.

When did CARDIO TEHCHANALYZER receive FDA 510(k) clearance?

CARDIO TEHCHANALYZER received FDA 510(k) clearance on 1982-10-04, under 510(k) number K821711.

Who is the listed applicant for CARDIO TEHCHANALYZER?

The FDA 510(k) record lists Cardio Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO TEHCHANALYZER?

The FDA product code for CARDIO TEHCHANALYZER 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.

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Other records listing Cardio Technology , Ltd. 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.

K830903CARDIO ARRHYTHMIA TRANSMITTER C.A.T

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

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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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