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FDA 510(k)

FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA

K-Number: K855094 · 1986-02-12

ApplicantFukuda Denshi USA, Inc.
Decision Date1986-02-12
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K855094. 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 FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA?

FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K855094.

When did FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA receive FDA 510(k) clearance?

FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA received FDA 510(k) clearance on 1986-02-12, under 510(k) number K855094.

Who is the listed applicant for FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA?

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

What is the FDA product code for FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA?

The FDA product code for FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA is DSI.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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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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