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FDA 510(k)

CARDIO-DATA SYSTEM, #MARK III

K-Number: K812149 · 1981-08-31

ApplicantCardio Data
Decision Date1981-08-31
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-DATA SYSTEM, #MARK III is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Data. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812149. 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-DATA SYSTEM, #MARK III?

CARDIO-DATA SYSTEM, #MARK III is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Cardio Data. The 510(k) number is K812149.

When did CARDIO-DATA SYSTEM, #MARK III receive FDA 510(k) clearance?

CARDIO-DATA SYSTEM, #MARK III received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812149.

Who is the listed applicant for CARDIO-DATA SYSTEM, #MARK III?

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

What is the FDA product code for CARDIO-DATA SYSTEM, #MARK III?

The FDA product code for CARDIO-DATA SYSTEM, #MARK III 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 Data 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.

K853262CARDIO DATA PACERECORDER PR3K850136CARDIO DATA MK4 HOLTER ANALYSIS SYSTEMK834257CARDIODATA PACE RECORDERK831184CARDIO DATA PACEMAKER RECORDERK770264PACEGUARD

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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