ADHEAR System
K-Number: K172460 · 2018-04-27
Decision Date2018-04-27
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
ADHEAR System is a medical device manufactured by Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2018-04-27 under approval number K172460. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ADHEAR System?
ADHEAR System is a medical device that received FDA 510(k) clearance on 2018-04-27. It is manufactured by Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K172460.
When was ADHEAR System approved by the FDA?
ADHEAR System received FDA 510(k) clearance on 2018-04-27, under approval number K172460.
What company makes ADHEAR System?
ADHEAR System is manufactured by Med-El Elektromedizinische Geraete GmbH.
What is the FDA product code for ADHEAR System?
The FDA product code for ADHEAR System is LXB.
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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.