SimplECG
K-Number: K161431 · 2016-11-30
ApplicantNanowear, Inc.
Decision Date2016-11-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SimplECG is a medical device manufactured by Nanowear, Inc.. It received FDA 510(k) clearance on 2016-11-30 under approval number K161431. 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 SimplECG?
SimplECG is a medical device that received FDA 510(k) clearance on 2016-11-30. It is manufactured by Nanowear, Inc.. The 510(k) number is K161431.
When was SimplECG approved by the FDA?
SimplECG received FDA 510(k) clearance on 2016-11-30, under approval number K161431.
What company makes SimplECG?
SimplECG is manufactured by Nanowear, Inc..
What is the FDA product code for SimplECG?
The FDA product code for SimplECG is DXH. This falls under the Hematology category.
Other Devices by Nanowear, 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.