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FDA 510(k)

FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR

K-Number: K971131 · 1997-10-03

ApplicantFukuda Denshi USA, Inc.
Decision Date1997-10-03
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR 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 1997-10-03 under 510(k) number K971131. 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 MODEL DS-5100E PORTABLE PATIENT MONITOR?

FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K971131.

When did FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR received FDA 510(k) clearance on 1997-10-03, under 510(k) number K971131.

Who is the listed applicant for FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR?

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 MODEL DS-5100E PORTABLE PATIENT MONITOR?

The FDA product code for FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR 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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