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FDA 510(k)

HEARTRAK

K-Number: K943124 · 1995-05-03

ApplicantUniversal Medical, Inc.
Decision Date1995-05-03
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTRAK is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical, Inc.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K943124. 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 HEARTRAK?

HEARTRAK is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Universal Medical, Inc.. The 510(k) number is K943124.

When did HEARTRAK receive FDA 510(k) clearance?

HEARTRAK received FDA 510(k) clearance on 1995-05-03, under 510(k) number K943124.

Who is the listed applicant for HEARTRAK?

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

What is the FDA product code for HEARTRAK?

The FDA product code for HEARTRAK is DXH. This falls under the Hematology category.

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 Universal Medical, 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.

K083535HEARTRAK SMART ECATK071130HEARTRAK AFK033451HEARTRAK SMART AT/HEARTRAK SMART2K980624CARDIOSTATIONK960499HEARTRAK XLK954495PACETRAK PLUS

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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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