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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 a medical device manufactured by Dizzydoctor Systems, LLC. It received FDA 510(k) clearance on 2018-09-14 under approval 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. It is manufactured by Dizzydoctor Systems, LLC. The 510(k) number is K182214.

When was DizzyDoctor System 1.0.0 approved by the FDA?

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

What company makes DizzyDoctor System 1.0.0?

DizzyDoctor System 1.0.0 is manufactured by Dizzydoctor Systems, LLC.

What is the FDA product code for DizzyDoctor System 1.0.0?

The FDA product code for DizzyDoctor System 1.0.0 is GWN.

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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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