Smith & Nephew DYONICS 25 Fluid Management System
K-Number: K192155 · 2019-09-04
ApplicantSmith & Nephew, Inc.
Decision Date2019-09-04
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Smith & Nephew DYONICS 25 Fluid Management System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2019-09-04 under approval number K192155. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Smith & Nephew DYONICS 25 Fluid Management System?
Smith & Nephew DYONICS 25 Fluid Management System is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K192155.
When was Smith & Nephew DYONICS 25 Fluid Management System approved by the FDA?
Smith & Nephew DYONICS 25 Fluid Management System received FDA 510(k) clearance on 2019-09-04, under approval number K192155.
What company makes Smith & Nephew DYONICS 25 Fluid Management System?
Smith & Nephew DYONICS 25 Fluid Management System is manufactured by Smith & Nephew, Inc..
What is the FDA product code for Smith & Nephew DYONICS 25 Fluid Management System?
The FDA product code for Smith & Nephew DYONICS 25 Fluid Management System is HRX.
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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.