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FDA 510(k)

QT ECG (QTERD100)

K-Number: K233521 · 2023-12-06

ApplicantQT Medical, Inc.
Decision Date2023-12-06
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QT ECG (QTERD100) is the device name listed in this FDA 510(k) record. The listed applicant is QT Medical, Inc.. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K233521. 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 QT ECG (QTERD100)?

QT ECG (QTERD100) is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is QT Medical, Inc.. The 510(k) number is K233521.

When did QT ECG (QTERD100) receive FDA 510(k) clearance?

QT ECG (QTERD100) received FDA 510(k) clearance on 2023-12-06, under 510(k) number K233521.

Who is the listed applicant for QT ECG (QTERD100)?

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

What is the FDA product code for QT ECG (QTERD100)?

The FDA product code for QT ECG (QTERD100) is DXH. This falls under the Hematology category.

Other records listing QT 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.

K220795QT ECGK200722PCA-C1 series Patient CableK180157QT ECG

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.K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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