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 a medical device manufactured by QT Medical, Inc.. It received FDA 510(k) clearance on 2023-12-06 under approval 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. It is manufactured by QT Medical, Inc.. The 510(k) number is K233521.
When was QT ECG (QTERD100) approved by the FDA?
QT ECG (QTERD100) received FDA 510(k) clearance on 2023-12-06, under approval number K233521.
What company makes QT ECG (QTERD100)?
QT ECG (QTERD100) is manufactured by QT Medical, Inc..
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 Devices by QT Medical, Inc.
Related Devices (Code: DXH)
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.