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FDA 510(k)

MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR

K-Number: K973863 · 1998-01-02

ApplicantHi-Tronics Designs, Inc.
Decision Date1998-01-02
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Tronics Designs, Inc.. It received FDA 510(k) clearance on 1998-01-02 under 510(k) number K973863. 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 MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR?

MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR is a medical device that received FDA 510(k) clearance on 1998-01-02. The listed applicant is Hi-Tronics Designs, Inc.. The 510(k) number is K973863.

When did MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR receive FDA 510(k) clearance?

MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR received FDA 510(k) clearance on 1998-01-02, under 510(k) number K973863.

Who is the listed applicant for MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR?

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

What is the FDA product code for MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR?

The FDA product code for MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR 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 Hi-Tronics Designs, 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.

K941898MEMORYTRACE ATM MODEL 4222

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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