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FDA 510(k)

COMPUTER ECG TERMINAL

K-Number: K771648 · 1977-09-20

ApplicantCompumed, Inc.
Decision Date1977-09-20
Product CodeDXH
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 1977-09-20 under 510(k) number K771648. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. 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 1977-09-20. The listed applicant is Compumed, Inc.. The 510(k) number is K771648.

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

COMPUTER ECG TERMINAL received FDA 510(k) clearance on 1977-09-20, under 510(k) number K771648.

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 DXH. This falls under the Hematology category.

Related Clinical Trials

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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 307BK802272COMPUTER ECG TERMINAL

Related Devices (Code: DXH)

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

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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