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FDA 510(k)

CARDIODATA PACE RECORDER

K-Number: K834257 · 1984-01-30

ApplicantCardio Data
Decision Date1984-01-30
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIODATA PACE 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 1984-01-30 under 510(k) number K834257. 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 CARDIODATA PACE RECORDER?

CARDIODATA PACE RECORDER is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Cardio Data. The 510(k) number is K834257.

When did CARDIODATA PACE RECORDER receive FDA 510(k) clearance?

CARDIODATA PACE RECORDER received FDA 510(k) clearance on 1984-01-30, under 510(k) number K834257.

Who is the listed applicant for CARDIODATA PACE 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 CARDIODATA PACE RECORDER?

The FDA product code for CARDIODATA PACE RECORDER is DSH.

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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 SYSTEMK831184CARDIO DATA PACEMAKER 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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