Decision Date2017-11-09
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MX40 Release B.07 is a medical device manufactured by Philips Medical Systems. It received FDA 510(k) clearance on 2017-11-09 under approval number K172226. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MX40 Release B.07?
MX40 Release B.07 is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Philips Medical Systems. The 510(k) number is K172226.
When was MX40 Release B.07 approved by the FDA?
MX40 Release B.07 received FDA 510(k) clearance on 2017-11-09, under approval number K172226.
What company makes MX40 Release B.07?
MX40 Release B.07 is manufactured by Philips Medical Systems.
What is the FDA product code for MX40 Release B.07?
The FDA product code for MX40 Release B.07 is MHX.
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Official Source
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