NHancer Rx
K-Number: K200324 · 2020-08-06
ApplicantImds Operations B.V.
Decision Date2020-08-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
NHancer Rx is a medical device manufactured by Imds Operations B.V.. It received FDA 510(k) clearance on 2020-08-06 under approval number K200324. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NHancer Rx?
NHancer Rx is a medical device that received FDA 510(k) clearance on 2020-08-06. It is manufactured by Imds Operations B.V.. The 510(k) number is K200324.
When was NHancer Rx approved by the FDA?
NHancer Rx received FDA 510(k) clearance on 2020-08-06, under approval number K200324.
What company makes NHancer Rx?
NHancer Rx is manufactured by Imds Operations B.V..
What is the FDA product code for NHancer Rx?
The FDA product code for NHancer Rx is DQY.
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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.