Philips Hemodynamic Application R1.0
K-Number: K181311 · 2018-09-07
Decision Date2018-09-07
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Philips Hemodynamic Application R1.0 is a medical device manufactured by Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2018-09-07 under approval number K181311. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Philips Hemodynamic Application R1.0?
Philips Hemodynamic Application R1.0 is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Philips Medical Systems Nederlands B.V.. The 510(k) number is K181311.
When was Philips Hemodynamic Application R1.0 approved by the FDA?
Philips Hemodynamic Application R1.0 received FDA 510(k) clearance on 2018-09-07, under approval number K181311.
What company makes Philips Hemodynamic Application R1.0?
Philips Hemodynamic Application R1.0 is manufactured by Philips Medical Systems Nederlands B.V..
What is the FDA product code for Philips Hemodynamic Application R1.0?
The FDA product code for Philips Hemodynamic Application R1.0 is MWI.
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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.