ECG Check - Universal, ECG Check - Universal Plus
K-Number: K170506 · 2017-10-02
ApplicantCardiac Designs, Inc.
Decision Date2017-10-02
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ECG Check - Universal, ECG Check - Universal Plus is a medical device manufactured by Cardiac Designs, Inc.. It received FDA 510(k) clearance on 2017-10-02 under approval number K170506. 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 Check - Universal, ECG Check - Universal Plus?
ECG Check - Universal, ECG Check - Universal Plus is a medical device that received FDA 510(k) clearance on 2017-10-02. It is manufactured by Cardiac Designs, Inc.. The 510(k) number is K170506.
When was ECG Check - Universal, ECG Check - Universal Plus approved by the FDA?
ECG Check - Universal, ECG Check - Universal Plus received FDA 510(k) clearance on 2017-10-02, under approval number K170506.
What company makes ECG Check - Universal, ECG Check - Universal Plus?
ECG Check - Universal, ECG Check - Universal Plus is manufactured by Cardiac Designs, Inc..
What is the FDA product code for ECG Check - Universal, ECG Check - Universal Plus?
The FDA product code for ECG Check - Universal, ECG Check - Universal Plus 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.