Reusable NIBP Cuff
K-Number: K173197 · 2018-08-21
ApplicantOrantech, Inc.
Decision Date2018-08-21
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Reusable NIBP Cuff is a medical device manufactured by Orantech, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K173197. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Reusable NIBP Cuff?
Reusable NIBP Cuff is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Orantech, Inc.. The 510(k) number is K173197.
When was Reusable NIBP Cuff approved by the FDA?
Reusable NIBP Cuff received FDA 510(k) clearance on 2018-08-21, under approval number K173197.
What company makes Reusable NIBP Cuff?
Reusable NIBP Cuff is manufactured by Orantech, Inc..
What is the FDA product code for Reusable NIBP Cuff?
The FDA product code for Reusable NIBP Cuff is DXQ.
Other Devices by Orantech, Inc.
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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.