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FDA 510(k)

SilentCloud

K-Number: K221125 · 2023-01-04

ApplicantAureliym GmbH
Decision Date2023-01-04
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SilentCloud is a medical device manufactured by Aureliym GmbH. It received FDA 510(k) clearance on 2023-01-04 under approval number K221125. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SilentCloud?

SilentCloud is a medical device that received FDA 510(k) clearance on 2023-01-04. It is manufactured by Aureliym GmbH. The 510(k) number is K221125.

When was SilentCloud approved by the FDA?

SilentCloud received FDA 510(k) clearance on 2023-01-04, under approval number K221125.

What company makes SilentCloud?

SilentCloud is manufactured by Aureliym GmbH.

What is the FDA product code for SilentCloud?

The FDA product code for SilentCloud is KLW.

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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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