Decision Date2018-04-27
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
ADHEAR System is the device name listed in this FDA 510(k) record. The listed applicant is Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2018-04-27 under 510(k) 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. The listed applicant is Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K172460.
When did ADHEAR System receive FDA 510(k) clearance?
ADHEAR System received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172460.
Who is the listed applicant for ADHEAR System?
The FDA 510(k) record lists Med-El Elektromedizinische Geraete GmbH as the applicant. This does not by itself establish the device manufacturer.
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.