Decision Date2019-04-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Erbe APCapplicators is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2019-04-04 under approval number K183445. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Erbe APCapplicators?
Erbe APCapplicators is a medical device that received FDA 510(k) clearance on 2019-04-04. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K183445.
When was Erbe APCapplicators approved by the FDA?
Erbe APCapplicators received FDA 510(k) clearance on 2019-04-04, under approval number K183445.
What company makes Erbe APCapplicators?
Erbe APCapplicators is manufactured by Erbe Elektromedizin GmbH.
What is the FDA product code for Erbe APCapplicators?
The FDA product code for Erbe APCapplicators is GEI.
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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.