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FDA 510(k)

CARDIO DATA PACEMAKER RECORDER

K-Number: K831184 · 1983-05-09

ApplicantCardio Data
Decision Date1983-05-09
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO DATA PACEMAKER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Data. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831184. 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 CARDIO DATA PACEMAKER RECORDER?

CARDIO DATA PACEMAKER RECORDER is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Cardio Data. The 510(k) number is K831184.

When did CARDIO DATA PACEMAKER RECORDER receive FDA 510(k) clearance?

CARDIO DATA PACEMAKER RECORDER received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831184.

Who is the listed applicant for CARDIO DATA PACEMAKER RECORDER?

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 PACEMAKER RECORDER?

The FDA product code for CARDIO DATA PACEMAKER RECORDER is DSH.

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 PR3K850136CARDIO DATA MK4 HOLTER ANALYSIS SYSTEMK834257CARDIODATA PACE RECORDERK812149CARDIO-DATA SYSTEM, #MARK IIIK770264PACEGUARD

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

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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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