Mediracer NCS
K-Number: K190536 · 2019-09-25
ApplicantMediracer OY
Decision Date2019-09-25
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Mediracer NCS is a medical device manufactured by Mediracer OY. It received FDA 510(k) clearance on 2019-09-25 under approval number K190536. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mediracer NCS?
Mediracer NCS is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Mediracer OY. The 510(k) number is K190536.
When was Mediracer NCS approved by the FDA?
Mediracer NCS received FDA 510(k) clearance on 2019-09-25, under approval number K190536.
What company makes Mediracer NCS?
Mediracer NCS is manufactured by Mediracer OY.
What is the FDA product code for Mediracer NCS?
The FDA product code for Mediracer NCS is JXE.
Related Devices (Code: JXE)
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.