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FDA 510(k)

ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)

K-Number: K962827 · 1997-02-24

ApplicantMarquette Electronics, Inc.
Decision Date1997-02-24
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1997-02-24 under 510(k) number K962827. 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 ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)?

ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) is a medical device that received FDA 510(k) clearance on 1997-02-24. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K962827.

When did ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) receive FDA 510(k) clearance?

ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) received FDA 510(k) clearance on 1997-02-24, under 510(k) number K962827.

Who is the listed applicant for ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)?

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

What is the FDA product code for ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)?

The FDA product code for ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) is DSI.

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Other records listing Marquette Electronics, 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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