← Product Code [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI) · K962827 # ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (K962827) _Marquette Electronics, Inc. · DSI · Feb 24, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K962827 ## Device Facts - **Applicant:** Marquette Electronics, Inc. - **Product Code:** [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI.md) - **Decision Date:** Feb 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1025 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual’s attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager. ## Device Story ADU/Pager-LAN System; receives event signals from central stations, telemetry systems, or bedside monitors; provides secondary annunciation of patient conditions; alerts clinical staff via pager device; intended to draw attention to specific zones/patients; does not replace primary monitoring; primary care workflow remains unchanged. ## Clinical Evidence Bench testing only; validation test results indicate device meets requirements for intended use. ## Technological Characteristics Pager-based alarm annunciation system; integrates with existing central station/telemetry/bedside monitoring infrastructure; provides zone-specific event notification. ## Regulatory Identification The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. ## Special Controls *Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K962827 2/24/97 Date: June 11th, 1996 ## Submitter/ Manufacturing Information The sponsor of this 510(k) Premarket Notification is: Marquette Electronics, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Establishment registration number is 2124823. The Pagers and People Finder Series are manufactured by: Motorola Inc. Paging Terminal Products Division 1500 NW 22nd Avenue Boynton Beach, CA 93426-8292 USA Any questions regarding the contents of this submission may be directed to: Dianne Schmitz Corporate Regulatory Affairs Marquette Electronics Inc. Phone: (414)362-3230 Fax: (414)355-3790 ## General Information ### Trade/ Proprietary Name Marquette Electronics, Inc. name for this device is the ADU/ Pager-LAN System. ### Common/ Usual Name This device is commonly known as a pager and an alarm display unit. ### Device Classification Unclassified according to a review performed of the CDRH Manual - FDA 91-4246 Classification Names for Medical Devices and In Vitro Diagnostic Products, as well as the Diogenes 510(k) Register and database. ### Performance Standards Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission. ### Device Description and Intended Use The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual’s attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager. ### Conclusion Validation test results indicate that the pager meets the requirements of its intended use. This information is secondary to the primary care provided. Primary care remains unchanged by the addition of a pager. 00010 62 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K962827](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K962827) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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