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FDA 510(k)

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile

K-Number: K181310 · 2019-02-22

ApplicantCardiocomm Solutions, Inc.
Decision Date2019-02-22
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocomm Solutions, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K181310. 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 HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Cardiocomm Solutions, Inc.. The 510(k) number is K181310.

When did HeartCheck Cardi Beat ECG Monitor with GEMS Mobile receive FDA 510(k) clearance?

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile received FDA 510(k) clearance on 2019-02-22, under 510(k) number K181310.

Who is the listed applicant for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

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

What is the FDA product code for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

The FDA product code for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile 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.

NCT07676227Pulse Oximetry Performance Test for PaMo - Controlled Desaturation TestCOMPLETEDNCT07776964Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)NOT_YET_RECRUITING

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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