SimpleSENSE Platform
K-Number: K212160 · 2021-09-22
ApplicantNanowear, Inc.
Decision Date2021-09-22
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SimpleSENSE Platform is a medical device manufactured by Nanowear, Inc.. It received FDA 510(k) clearance on 2021-09-22 under approval number K212160. 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 Platform?
SimpleSENSE Platform is a medical device that received FDA 510(k) clearance on 2021-09-22. It is manufactured by Nanowear, Inc.. The 510(k) number is K212160.
When was SimpleSENSE Platform approved by the FDA?
SimpleSENSE Platform received FDA 510(k) clearance on 2021-09-22, under approval number K212160.
What company makes SimpleSENSE Platform?
SimpleSENSE Platform is manufactured by Nanowear, Inc..
What is the FDA product code for SimpleSENSE Platform?
The FDA product code for SimpleSENSE Platform 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.