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FDA 510(k)

DizzyDoctor System 1.0.0

K-Number: K182214 · 2018-09-14

ApplicantDizzydoctor Systems, LLC
Decision Date2018-09-14
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DizzyDoctor System 1.0.0 is the device name listed in this FDA 510(k) record. The listed applicant is Dizzydoctor Systems, LLC. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K182214. 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 DizzyDoctor System 1.0.0?

DizzyDoctor System 1.0.0 is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Dizzydoctor Systems, LLC. The 510(k) number is K182214.

When did DizzyDoctor System 1.0.0 receive FDA 510(k) clearance?

DizzyDoctor System 1.0.0 received FDA 510(k) clearance on 2018-09-14, under 510(k) number K182214.

Who is the listed applicant for DizzyDoctor System 1.0.0?

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

What is the FDA product code for DizzyDoctor System 1.0.0?

The FDA product code for DizzyDoctor System 1.0.0 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 ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

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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