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FDA 510(k)

Synq Software Version 1.3

K-Number: K232981 · 2023-10-11

ApplicantSynaptive Medical, Inc.
Decision Date2023-10-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synq Software Version 1.3 is a medical device manufactured by Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2023-10-11 under approval number K232981. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synq Software Version 1.3?

Synq Software Version 1.3 is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by Synaptive Medical, Inc.. The 510(k) number is K232981.

When was Synq Software Version 1.3 approved by the FDA?

Synq Software Version 1.3 received FDA 510(k) clearance on 2023-10-11, under approval number K232981.

What company makes Synq Software Version 1.3?

Synq Software Version 1.3 is manufactured by Synaptive Medical, Inc..

What is the FDA product code for Synq Software Version 1.3?

The FDA product code for Synq Software Version 1.3 is LNH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

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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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