Infinity M300
K-Number: K200859 · 2020-08-28
ApplicantDraeger Medical Systems, Inc.
Decision Date2020-08-28
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Infinity M300 is a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-08-28 under approval number K200859. 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 Infinity M300?
Infinity M300 is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K200859.
When was Infinity M300 approved by the FDA?
Infinity M300 received FDA 510(k) clearance on 2020-08-28, under approval number K200859.
What company makes Infinity M300?
Infinity M300 is manufactured by Draeger Medical Systems, Inc..
What is the FDA product code for Infinity M300?
The FDA product code for Infinity M300 is MHX.
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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.