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FDA 510(k)

TINNITUS THERAPY SYSTEM ANM T30 CR

K-Number: K112752 · 2011-12-16

ApplicantAnm Adaptive Neuromodulation GmbH
Decision Date2011-12-16
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TINNITUS THERAPY SYSTEM ANM T30 CR is the device name listed in this FDA 510(k) record. The listed applicant is Anm Adaptive Neuromodulation GmbH. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K112752. 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 TINNITUS THERAPY SYSTEM ANM T30 CR?

TINNITUS THERAPY SYSTEM ANM T30 CR is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Anm Adaptive Neuromodulation GmbH. The 510(k) number is K112752.

When did TINNITUS THERAPY SYSTEM ANM T30 CR receive FDA 510(k) clearance?

TINNITUS THERAPY SYSTEM ANM T30 CR received FDA 510(k) clearance on 2011-12-16, under 510(k) number K112752.

Who is the listed applicant for TINNITUS THERAPY SYSTEM ANM T30 CR?

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

What is the FDA product code for TINNITUS THERAPY SYSTEM ANM T30 CR?

The FDA product code for TINNITUS THERAPY SYSTEM ANM T30 CR is KLW.

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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.

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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.

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