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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Nanowear, Inc.. It received FDA 510(k) clearance on 2021-09-22 under 510(k) 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. The listed applicant is Nanowear, Inc.. The 510(k) number is K212160.

When did SimpleSENSE Platform receive FDA 510(k) clearance?

SimpleSENSE Platform received FDA 510(k) clearance on 2021-09-22, under 510(k) number K212160.

Who is the listed applicant for SimpleSENSE Platform?

The FDA 510(k) record lists Nanowear, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Nanowear, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232053SimpleSense-BP, SimpleSense-BP Software ApplicationK201669SimpleSENSEK161431SimplECG

Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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