FDA 510(k)

SilentCloud

K-Number: K221125 · 2023-01-04

Decision Date2023-01-04

Product CodeKLW

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

SilentCloud is the device name listed in this FDA 510(k) record. The listed applicant is Aureliym GmbH. It received FDA 510(k) clearance on 2023-01-04 under 510(k) 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. The listed applicant is Aureliym GmbH. The 510(k) number is K221125.

When did SilentCloud receive FDA 510(k) clearance?

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

Who is the listed applicant for SilentCloud?

The FDA 510(k) record lists Aureliym GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SilentCloud?

The FDA product code for SilentCloud is KLW.

Related Devices (Code: KLW)

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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical Corporation K260614Tinnitus TherapySivantos GmbH K233435Peace N Quiet (0.7.0)Pnq Health K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.

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.