Noiselezz
K-Number: K160531 · 2016-09-01
ApplicantFirma Ingemarsson
Decision Date2016-09-01
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Noiselezz is a medical device manufactured by Firma Ingemarsson. It received FDA 510(k) clearance on 2016-09-01 under approval 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. It is manufactured by Firma Ingemarsson. The 510(k) number is K160531.
When was Noiselezz approved by the FDA?
Noiselezz received FDA 510(k) clearance on 2016-09-01, under approval number K160531.
What company makes Noiselezz?
Noiselezz is manufactured by Firma Ingemarsson.
What is the FDA product code for Noiselezz?
The FDA product code for Noiselezz is LRK.
Related Devices (Code: LRK)
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.