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FDA 510(k)

IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS

K-Number: K830163 · 1983-02-18

ApplicantIntl. Business Machines
Decision Date1983-02-18
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Business Machines. It received FDA 510(k) clearance on 1983-02-18 under 510(k) number K830163. 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 IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS?

IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is Intl. Business Machines. The 510(k) number is K830163.

When did IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS receive FDA 510(k) clearance?

IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS received FDA 510(k) clearance on 1983-02-18, under 510(k) number K830163.

Who is the listed applicant for IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS?

The FDA 510(k) record lists Intl. Business Machines as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS?

The FDA product code for IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS is DSI.

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Other records listing Intl. Business Machines as applicant

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.

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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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