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FDA 510(k)

CARDIONOSTICS HOLTER DURA-LITE RECORDE

K-Number: K842954 · 1984-09-04

ApplicantCardionostics, Inc.
Decision Date1984-09-04
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIONOSTICS HOLTER DURA-LITE RECORDE is the device name listed in this FDA 510(k) record. The listed applicant is Cardionostics, Inc.. It received FDA 510(k) clearance on 1984-09-04 under 510(k) number K842954. 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 CARDIONOSTICS HOLTER DURA-LITE RECORDE?

CARDIONOSTICS HOLTER DURA-LITE RECORDE is a medical device that received FDA 510(k) clearance on 1984-09-04. The listed applicant is Cardionostics, Inc.. The 510(k) number is K842954.

When did CARDIONOSTICS HOLTER DURA-LITE RECORDE receive FDA 510(k) clearance?

CARDIONOSTICS HOLTER DURA-LITE RECORDE received FDA 510(k) clearance on 1984-09-04, under 510(k) number K842954.

Who is the listed applicant for CARDIONOSTICS HOLTER DURA-LITE RECORDE?

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

What is the FDA product code for CARDIONOSTICS HOLTER DURA-LITE RECORDE?

The FDA product code for CARDIONOSTICS HOLTER DURA-LITE RECORDE is DSH.

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 Cardionostics, Inc. 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.

K902486CARDIOVISTAK863863CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)K844977HOLTER CURA-LITE RECORDER

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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