NR Recorder
K-Number: K161062 · 2016-06-13
ApplicantNorav Medical GmbH
Decision Date2016-06-13
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
NR Recorder is a medical device manufactured by Norav Medical GmbH. It received FDA 510(k) clearance on 2016-06-13 under approval number K161062. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NR Recorder?
NR Recorder is a medical device that received FDA 510(k) clearance on 2016-06-13. It is manufactured by Norav Medical GmbH. The 510(k) number is K161062.
When was NR Recorder approved by the FDA?
NR Recorder received FDA 510(k) clearance on 2016-06-13, under approval number K161062.
What company makes NR Recorder?
NR Recorder is manufactured by Norav Medical GmbH.
What is the FDA product code for NR Recorder?
The FDA product code for NR Recorder is MWJ.
Related Devices (Code: MWJ)
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.