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FDA 510(k)

DMI AMBULATORY HOLTER MONITOR

K-Number: K871045 · 1987-05-19

ApplicantDiagnostic Medical Instruments
Decision Date1987-05-19
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DMI AMBULATORY HOLTER MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Medical Instruments. It received FDA 510(k) clearance on 1987-05-19 under 510(k) number K871045. 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 DMI AMBULATORY HOLTER MONITOR?

DMI AMBULATORY HOLTER MONITOR is a medical device that received FDA 510(k) clearance on 1987-05-19. The listed applicant is Diagnostic Medical Instruments. The 510(k) number is K871045.

When did DMI AMBULATORY HOLTER MONITOR receive FDA 510(k) clearance?

DMI AMBULATORY HOLTER MONITOR received FDA 510(k) clearance on 1987-05-19, under 510(k) number K871045.

Who is the listed applicant for DMI AMBULATORY HOLTER MONITOR?

The FDA 510(k) record lists Diagnostic Medical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DMI AMBULATORY HOLTER MONITOR?

The FDA product code for DMI AMBULATORY HOLTER MONITOR 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 Diagnostic Medical Instruments 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.

K912728ALTAIRK894285DMI PC HOLTER SCANNERK830489RECORDER DMIK830407ECLIPSE

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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