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FDA 510(k)

Synapsys VHIT

K-Number: K242726 · 2025-01-03

ApplicantInventis S.R.L.
Decision Date2025-01-03
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Synapsys VHIT is the device name listed in this FDA 510(k) record. The listed applicant is Inventis S.R.L.. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K242726. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synapsys VHIT?

Synapsys VHIT is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Inventis S.R.L.. The 510(k) number is K242726.

When did Synapsys VHIT receive FDA 510(k) clearance?

Synapsys VHIT received FDA 510(k) clearance on 2025-01-03, under 510(k) number K242726.

Who is the listed applicant for Synapsys VHIT?

The FDA 510(k) record lists Inventis S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synapsys VHIT?

The FDA product code for Synapsys VHIT is GWN.

Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular FirstK200534VisualEyesInteracoustics A/S

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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