ECG SENTINEL System
K-Number: K172801 · 2017-10-18
ApplicantCardiomedix, Inc.
Decision Date2017-10-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ECG SENTINEL System is a medical device manufactured by Cardiomedix, Inc.. It received FDA 510(k) clearance on 2017-10-18 under approval number K172801. 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 ECG SENTINEL System?
ECG SENTINEL System is a medical device that received FDA 510(k) clearance on 2017-10-18. It is manufactured by Cardiomedix, Inc.. The 510(k) number is K172801.
When was ECG SENTINEL System approved by the FDA?
ECG SENTINEL System received FDA 510(k) clearance on 2017-10-18, under approval number K172801.
What company makes ECG SENTINEL System?
ECG SENTINEL System is manufactured by Cardiomedix, Inc..
What is the FDA product code for ECG SENTINEL System?
The FDA product code for ECG SENTINEL System is DXH. This falls under the Hematology category.
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.