bite away neo
K-Number: K220514 · 2022-06-23
ApplicantmibeTec GmbH
Decision Date2022-06-23
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
bite away neo is a medical device manufactured by mibeTec GmbH. It received FDA 510(k) clearance on 2022-06-23 under approval number K220514. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the bite away neo?
bite away neo is a medical device that received FDA 510(k) clearance on 2022-06-23. It is manufactured by mibeTec GmbH. The 510(k) number is K220514.
When was bite away neo approved by the FDA?
bite away neo received FDA 510(k) clearance on 2022-06-23, under approval number K220514.
What company makes bite away neo?
bite away neo is manufactured by mibeTec GmbH.
What is the FDA product code for bite away neo?
The FDA product code for bite away neo is IRT.
Other Devices by mibeTec GmbH
Related Devices (Code: IRT)
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.