Otoplan
K-Number: K203486 · 2021-08-20
ApplicantCascination AG
Decision Date2021-08-20
Product CodeQQE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Otoplan is a medical device manufactured by Cascination AG. It received FDA 510(k) clearance on 2021-08-20 under approval number K203486. The device is classified under product code QQE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Otoplan?
Otoplan is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Cascination AG. The 510(k) number is K203486.
When was Otoplan approved by the FDA?
Otoplan received FDA 510(k) clearance on 2021-08-20, under approval number K203486.
What company makes Otoplan?
Otoplan is manufactured by Cascination AG.
What is the FDA product code for Otoplan?
The FDA product code for Otoplan is QQE.
Other Devices by Cascination AG
Related Devices (Code: QQE)
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.