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FDA 510(k)

COMPUTER ECG TERMINAL

K-Number: K802272 · 1980-09-26

ApplicantCompumed, Inc.
Decision Date1980-09-26
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPUTER ECG TERMINAL is the device name listed in this FDA 510(k) record. The listed applicant is Compumed, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802272. 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 COMPUTER ECG TERMINAL?

COMPUTER ECG TERMINAL is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Compumed, Inc.. The 510(k) number is K802272.

When did COMPUTER ECG TERMINAL receive FDA 510(k) clearance?

COMPUTER ECG TERMINAL received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802272.

Who is the listed applicant for COMPUTER ECG TERMINAL?

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

What is the FDA product code for COMPUTER ECG TERMINAL?

The FDA product code for COMPUTER ECG TERMINAL is DSI.

Related Clinical Trials

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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Other records listing Compumed, Inc. 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.

K984285OSTEOGRAM BONE DENSITOMETERK955708COMPUMED DICON CLIENTK863965KENZ-ECG 102K854626COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307BK771648COMPUTER ECG TERMINAL

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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