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FDA 510(k)

SINGLE BED ARRHYTHMIA MONITOR AM500

K-Number: K831638 · 1983-11-14

ApplicantLifeline Systems, Inc.
Decision Date1983-11-14
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SINGLE BED ARRHYTHMIA MONITOR AM500 is the device name listed in this FDA 510(k) record. The listed applicant is Lifeline Systems, Inc.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K831638. 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 SINGLE BED ARRHYTHMIA MONITOR AM500?

SINGLE BED ARRHYTHMIA MONITOR AM500 is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Lifeline Systems, Inc.. The 510(k) number is K831638.

When did SINGLE BED ARRHYTHMIA MONITOR AM500 receive FDA 510(k) clearance?

SINGLE BED ARRHYTHMIA MONITOR AM500 received FDA 510(k) clearance on 1983-11-14, under 510(k) number K831638.

Who is the listed applicant for SINGLE BED ARRHYTHMIA MONITOR AM500?

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

What is the FDA product code for SINGLE BED ARRHYTHMIA MONITOR AM500?

The FDA product code for SINGLE BED ARRHYTHMIA MONITOR AM500 is DSI.

Related Clinical Trials

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Other records listing Lifeline Systems, 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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