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FDA 510(k)

SWITCH TRT

K-Number: K091552 · 2009-08-12

ApplicantAudifon GmbH & Co. KG
Decision Date2009-08-12
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SWITCH TRT is the device name listed in this FDA 510(k) record. The listed applicant is Audifon GmbH & Co. KG. It received FDA 510(k) clearance on 2009-08-12 under 510(k) number K091552. 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 SWITCH TRT?

SWITCH TRT is a medical device that received FDA 510(k) clearance on 2009-08-12. The listed applicant is Audifon GmbH & Co. KG. The 510(k) number is K091552.

When did SWITCH TRT receive FDA 510(k) clearance?

SWITCH TRT received FDA 510(k) clearance on 2009-08-12, under 510(k) number K091552.

Who is the listed applicant for SWITCH TRT?

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

What is the FDA product code for SWITCH TRT?

The FDA product code for SWITCH TRT is KLW.

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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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