Oral Device OA, Oral Device S
K-Number: K181396 · 2018-11-16
Decision Date2018-11-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Oral Device OA, Oral Device S is a medical device manufactured by Passion For Life Healthcare (Uk) Limited. It received FDA 510(k) clearance on 2018-11-16 under approval number K181396. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Oral Device OA, Oral Device S?
Oral Device OA, Oral Device S is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Passion For Life Healthcare (Uk) Limited. The 510(k) number is K181396.
When was Oral Device OA, Oral Device S approved by the FDA?
Oral Device OA, Oral Device S received FDA 510(k) clearance on 2018-11-16, under approval number K181396.
What company makes Oral Device OA, Oral Device S?
Oral Device OA, Oral Device S is manufactured by Passion For Life Healthcare (Uk) Limited.
What is the FDA product code for Oral Device OA, Oral Device S?
The FDA product code for Oral Device OA, Oral Device S is LRK.
Related Devices (Code: LRK)
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.