Infinity Gateway Suite
K-Number: K233834 · 2024-07-12
ApplicantDraeger Medical Systems, Inc.
Decision Date2024-07-12
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Infinity Gateway Suite is a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-07-12 under approval number K233834. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Infinity Gateway Suite?
Infinity Gateway Suite is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K233834.
When was Infinity Gateway Suite approved by the FDA?
Infinity Gateway Suite received FDA 510(k) clearance on 2024-07-12, under approval number K233834.
What company makes Infinity Gateway Suite?
Infinity Gateway Suite is manufactured by Draeger Medical Systems, Inc..
What is the FDA product code for Infinity Gateway Suite?
The FDA product code for Infinity Gateway Suite is MSX.
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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.