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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 the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-06-07 under 510(k) 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. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K203579.

When did Infinity Gateway Suite receive FDA 510(k) clearance?

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

Who is the listed applicant for Infinity Gateway Suite?

The FDA 510(k) record lists Draeger Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinity Gateway Suite?

The FDA product code for Infinity Gateway Suite is MSX.

Other records listing Draeger Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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