Planmed Clarity 2D and Clarity S
K-Number: K192317 · 2020-10-23
ApplicantPlanmed OY
Decision Date2020-10-23
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Planmed Clarity 2D and Clarity S is a medical device manufactured by Planmed OY. It received FDA 510(k) clearance on 2020-10-23 under approval number K192317. 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 2D and Clarity S?
Planmed Clarity 2D and Clarity S is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Planmed OY. The 510(k) number is K192317.
When was Planmed Clarity 2D and Clarity S approved by the FDA?
Planmed Clarity 2D and Clarity S received FDA 510(k) clearance on 2020-10-23, under approval number K192317.
What company makes Planmed Clarity 2D and Clarity S?
Planmed Clarity 2D and Clarity S is manufactured by Planmed OY.
What is the FDA product code for Planmed Clarity 2D and Clarity S?
The FDA product code for Planmed Clarity 2D and Clarity S 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.