SimpleSENSE
K-Number: K201669 · 2020-11-06
ApplicantNanowear, Inc.
Decision Date2020-11-06
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SimpleSENSE is a medical device manufactured by Nanowear, Inc.. It received FDA 510(k) clearance on 2020-11-06 under approval number K201669. 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 SimpleSENSE?
SimpleSENSE is a medical device that received FDA 510(k) clearance on 2020-11-06. It is manufactured by Nanowear, Inc.. The 510(k) number is K201669.
When was SimpleSENSE approved by the FDA?
SimpleSENSE received FDA 510(k) clearance on 2020-11-06, under approval number K201669.
What company makes SimpleSENSE?
SimpleSENSE is manufactured by Nanowear, Inc..
What is the FDA product code for SimpleSENSE?
The FDA product code for SimpleSENSE 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.