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FDA 510(k)

CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM

K-Number: K850136 · 1985-02-01

ApplicantCardio Data
Decision Date1985-02-01
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Data. It received FDA 510(k) clearance on 1985-02-01 under 510(k) number K850136. 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 MK4 HOLTER ANALYSIS SYSTEM?

CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Cardio Data. The 510(k) number is K850136.

When did CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM receive FDA 510(k) clearance?

CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM received FDA 510(k) clearance on 1985-02-01, under 510(k) number K850136.

Who is the listed applicant for CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM?

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 MK4 HOLTER ANALYSIS SYSTEM?

The FDA product code for CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM is DSI.

Related Clinical Trials

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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 PR3K834257CARDIODATA PACE RECORDERK831184CARDIO DATA PACEMAKER RECORDERK812149CARDIO-DATA SYSTEM, #MARK IIIK770264PACEGUARD

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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