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FDA 510(k)

SoloAsisst II, Voice Control

K-Number: K200473 · 2020-12-22

ApplicantAktormed GmbH
Decision Date2020-12-22
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SoloAsisst II, Voice Control is a medical device manufactured by Aktormed GmbH. It received FDA 510(k) clearance on 2020-12-22 under approval number K200473. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SoloAsisst II, Voice Control?

SoloAsisst II, Voice Control is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Aktormed GmbH. The 510(k) number is K200473.

When was SoloAsisst II, Voice Control approved by the FDA?

SoloAsisst II, Voice Control received FDA 510(k) clearance on 2020-12-22, under approval number K200473.

What company makes SoloAsisst II, Voice Control?

SoloAsisst II, Voice Control is manufactured by Aktormed GmbH.

What is the FDA product code for SoloAsisst II, Voice Control?

The FDA product code for SoloAsisst II, Voice Control is NAY.

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Other Devices by Aktormed GmbH

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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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