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FDA 510(k)

ARRHYTHMIA CENTRAL OCC-7101

K-Number: K843287 · 1984-10-18

ApplicantNihon Kohden America, Inc.
Decision Date1984-10-18
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARRHYTHMIA CENTRAL OCC-7101 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1984-10-18 under 510(k) number K843287. 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 ARRHYTHMIA CENTRAL OCC-7101?

ARRHYTHMIA CENTRAL OCC-7101 is a medical device that received FDA 510(k) clearance on 1984-10-18. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K843287.

When did ARRHYTHMIA CENTRAL OCC-7101 receive FDA 510(k) clearance?

ARRHYTHMIA CENTRAL OCC-7101 received FDA 510(k) clearance on 1984-10-18, under 510(k) number K843287.

Who is the listed applicant for ARRHYTHMIA CENTRAL OCC-7101?

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

What is the FDA product code for ARRHYTHMIA CENTRAL OCC-7101?

The FDA product code for ARRHYTHMIA CENTRAL OCC-7101 is DSI.

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Other records listing Nihon Kohden America, 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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