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FDA 510(k)

SimpleSense-BP, SimpleSense-BP Software Application

K-Number: K232053 · 2023-12-08

ApplicantNanowear, Inc.
Decision Date2023-12-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SimpleSense-BP, SimpleSense-BP Software Application is a medical device manufactured by Nanowear, Inc.. It received FDA 510(k) clearance on 2023-12-08 under approval number K232053. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimpleSense-BP, SimpleSense-BP Software Application?

SimpleSense-BP, SimpleSense-BP Software Application is a medical device that received FDA 510(k) clearance on 2023-12-08. It is manufactured by Nanowear, Inc.. The 510(k) number is K232053.

When was SimpleSense-BP, SimpleSense-BP Software Application approved by the FDA?

SimpleSense-BP, SimpleSense-BP Software Application received FDA 510(k) clearance on 2023-12-08, under approval number K232053.

What company makes SimpleSense-BP, SimpleSense-BP Software Application?

SimpleSense-BP, SimpleSense-BP Software Application is manufactured by Nanowear, Inc..

What is the FDA product code for SimpleSense-BP, SimpleSense-BP Software Application?

The FDA product code for SimpleSense-BP, SimpleSense-BP Software Application is DXN.

Related Clinical Trials

NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT07084779 Investigation of Impact of AI on Prostate Cancer Workflow RECRUITING NCT06257069 Tremor Retrainer Software Application for Functional Tremor ACTIVE_NOT_RECRUITING NCT06366867 An Open Platform of Serious Games for Cognitive Intervention COMPLETED NCT06052891 CHAMP For the Feeder: Tube Feeding Study ENROLLING_BY_INVITATION NCT04969757 Use of Predigraft in Kidney Transplant Patients COMPLETED

Related PubMed Literature

PMID: 39698124 Advancements in Clinical Evaluation and Regulatory Frameworks for AI-Driven Software as a Medical Device (SaMD). IEEE open journal of engineering in medicine and biology (2025) PMID: 25644202 Regulatory frameworks for mobile medical applications. Expert review of medical devices (2015)

Other Devices by Nanowear, Inc.

K161431SimplECG K201669SimpleSENSE K212160SimpleSENSE Platform

Related Devices (Code: DXN)

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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.

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