twion
K-Number: K151717 · 2016-02-23
ApplicantAlber GmbH
Decision Date2016-02-23
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
twion is a medical device manufactured by Alber GmbH. It received FDA 510(k) clearance on 2016-02-23 under approval number K151717. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the twion?
twion is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by Alber GmbH. The 510(k) number is K151717.
When was twion approved by the FDA?
twion received FDA 510(k) clearance on 2016-02-23, under approval number K151717.
What company makes twion?
twion is manufactured by Alber GmbH.
What is the FDA product code for twion?
The FDA product code for twion is ITI.
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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.