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FDA 510(k)

HOLTER CURA-LITE RECORDER

K-Number: K844977 · 1985-01-14

ApplicantCardionostics, Inc.
Decision Date1985-01-14
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER CURA-LITE RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Cardionostics, Inc.. It received FDA 510(k) clearance on 1985-01-14 under 510(k) number K844977. 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 HOLTER CURA-LITE RECORDER?

HOLTER CURA-LITE RECORDER is a medical device that received FDA 510(k) clearance on 1985-01-14. The listed applicant is Cardionostics, Inc.. The 510(k) number is K844977.

When did HOLTER CURA-LITE RECORDER receive FDA 510(k) clearance?

HOLTER CURA-LITE RECORDER received FDA 510(k) clearance on 1985-01-14, under 510(k) number K844977.

Who is the listed applicant for HOLTER CURA-LITE RECORDER?

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 HOLTER CURA-LITE RECORDER?

The FDA product code for HOLTER CURA-LITE RECORDER is DSH.

Related Clinical Trials

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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)K842954CARDIONOSTICS HOLTER DURA-LITE RECORDE

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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