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FDA 510(k)

Infinity Gateway Suite

K-Number: K203579 · 2022-06-07

ApplicantDraeger Medical Systems, Inc.
Decision Date2022-06-07
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 2022-06-07 under approval number K203579. 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 2022-06-07. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K203579.

When was Infinity Gateway Suite approved by the FDA?

Infinity Gateway Suite received FDA 510(k) clearance on 2022-06-07, under approval number K203579.

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.

Other Devices by Draeger Medical Systems, Inc.

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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.

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