TOF-Cuff monitor
K-Number: K181894 · 2019-05-09
ApplicantRgb Medical Devices SA
Decision Date2019-05-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TOF-Cuff monitor is a medical device manufactured by Rgb Medical Devices SA. It received FDA 510(k) clearance on 2019-05-09 under approval number K181894. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TOF-Cuff monitor?
TOF-Cuff monitor is a medical device that received FDA 510(k) clearance on 2019-05-09. It is manufactured by Rgb Medical Devices SA. The 510(k) number is K181894.
When was TOF-Cuff monitor approved by the FDA?
TOF-Cuff monitor received FDA 510(k) clearance on 2019-05-09, under approval number K181894.
What company makes TOF-Cuff monitor?
TOF-Cuff monitor is manufactured by Rgb Medical Devices SA.
What is the FDA product code for TOF-Cuff monitor?
The FDA product code for TOF-Cuff monitor is DXN.
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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.