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FDA 510(k)

ALGORITHM OF THE ARRHYTHMIA MON. SYS

K-Number: K820477 · 1982-04-15

ApplicantHewlett-Packard Co.
Decision Date1982-04-15
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALGORITHM OF THE ARRHYTHMIA MON. SYS is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820477. 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 ALGORITHM OF THE ARRHYTHMIA MON. SYS?

ALGORITHM OF THE ARRHYTHMIA MON. SYS is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K820477.

When did ALGORITHM OF THE ARRHYTHMIA MON. SYS receive FDA 510(k) clearance?

ALGORITHM OF THE ARRHYTHMIA MON. SYS received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820477.

Who is the listed applicant for ALGORITHM OF THE ARRHYTHMIA MON. SYS?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGORITHM OF THE ARRHYTHMIA MON. SYS?

The FDA product code for ALGORITHM OF THE ARRHYTHMIA MON. SYS is DSI.

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Other records listing Hewlett-Packard Co. 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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