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FDA 510(k)

HORIZON 2000 ARRHYTHMIA MONITORING OPTION

K-Number: K881273 · 1988-07-12

ApplicantMennen Medical, Inc.
Decision Date1988-07-12
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON 2000 ARRHYTHMIA MONITORING OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical, Inc.. It received FDA 510(k) clearance on 1988-07-12 under 510(k) number K881273. 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 HORIZON 2000 ARRHYTHMIA MONITORING OPTION?

HORIZON 2000 ARRHYTHMIA MONITORING OPTION is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K881273.

When did HORIZON 2000 ARRHYTHMIA MONITORING OPTION receive FDA 510(k) clearance?

HORIZON 2000 ARRHYTHMIA MONITORING OPTION received FDA 510(k) clearance on 1988-07-12, under 510(k) number K881273.

Who is the listed applicant for HORIZON 2000 ARRHYTHMIA MONITORING OPTION?

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

What is the FDA product code for HORIZON 2000 ARRHYTHMIA MONITORING OPTION?

The FDA product code for HORIZON 2000 ARRHYTHMIA MONITORING OPTION is DSI.

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Other records listing Mennen Medical, 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.

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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

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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