FDA 510(k)

Noiselezz

K-Number: K160531 · 2016-09-01

Decision Date2016-09-01

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Noiselezz is the device name listed in this FDA 510(k) record. The listed applicant is Firma Ingemarsson. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K160531. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Noiselezz?

Noiselezz is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Firma Ingemarsson. The 510(k) number is K160531.

When did Noiselezz receive FDA 510(k) clearance?

Noiselezz received FDA 510(k) clearance on 2016-09-01, under 510(k) number K160531.

Who is the listed applicant for Noiselezz?

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

What is the FDA product code for Noiselezz?

The FDA product code for Noiselezz is LRK.

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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.