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FDA 510(k)

DMI PC HOLTER SCANNER

K-Number: K894285 · 1989-09-26

ApplicantDiagnostic Medical Instruments
Decision Date1989-09-26
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DMI PC HOLTER SCANNER 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 1989-09-26 under 510(k) number K894285. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMI PC HOLTER SCANNER?

DMI PC HOLTER SCANNER is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Diagnostic Medical Instruments. The 510(k) number is K894285.

When did DMI PC HOLTER SCANNER receive FDA 510(k) clearance?

DMI PC HOLTER SCANNER received FDA 510(k) clearance on 1989-09-26, under 510(k) number K894285.

Who is the listed applicant for DMI PC HOLTER SCANNER?

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 PC HOLTER SCANNER?

The FDA product code for DMI PC HOLTER SCANNER is DSI.

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.

K912728ALTAIRK871045DMI AMBULATORY HOLTER MONITORK830489RECORDER DMIK830407ECLIPSE

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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