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FDA 510(k)

Compex HD

K-Number: K182017 · 2019-04-29

ApplicantAddent, Inc.
Decision Date2019-04-29
Product CodeQGO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Compex HD is a medical device manufactured by Addent, Inc.. It received FDA 510(k) clearance on 2019-04-29 under approval number K182017. The device is classified under product code QGO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Compex HD?

Compex HD is a medical device that received FDA 510(k) clearance on 2019-04-29. It is manufactured by Addent, Inc.. The 510(k) number is K182017.

When was Compex HD approved by the FDA?

Compex HD received FDA 510(k) clearance on 2019-04-29, under approval number K182017.

What company makes Compex HD?

Compex HD is manufactured by Addent, Inc..

What is the FDA product code for Compex HD?

The FDA product code for Compex HD is QGO.

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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