Planmed Clarity
K-Number: K163328 · 2017-12-28
ApplicantPlanmed OY
Decision Date2017-12-28
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Planmed Clarity is a medical device manufactured by Planmed OY. It received FDA 510(k) clearance on 2017-12-28 under approval number K163328. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Planmed Clarity?
Planmed Clarity is a medical device that received FDA 510(k) clearance on 2017-12-28. It is manufactured by Planmed OY. The 510(k) number is K163328.
When was Planmed Clarity approved by the FDA?
Planmed Clarity received FDA 510(k) clearance on 2017-12-28, under approval number K163328.
What company makes Planmed Clarity?
Planmed Clarity is manufactured by Planmed OY.
What is the FDA product code for Planmed Clarity?
The FDA product code for Planmed Clarity is MUE.
Other Devices by Planmed OY
Related Devices (Code: MUE)
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.