Sera
K-Number: K173567 · 2018-02-14
ApplicantInteracoustics A/S
Decision Date2018-02-14
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Sera is a medical device manufactured by Interacoustics A/S. It received FDA 510(k) clearance on 2018-02-14 under approval number K173567. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sera?
Sera is a medical device that received FDA 510(k) clearance on 2018-02-14. It is manufactured by Interacoustics A/S. The 510(k) number is K173567.
When was Sera approved by the FDA?
Sera received FDA 510(k) clearance on 2018-02-14, under approval number K173567.
What company makes Sera?
Sera is manufactured by Interacoustics A/S.
What is the FDA product code for Sera?
The FDA product code for Sera is EWO.
Other Devices by Interacoustics A/S
Related Devices (Code: EWO)
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.