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FDA 510(k)

Infinity CentralStation Wide, Infinity M300, Infinity M300+

K-Number: K231477 · 2023-10-17

ApplicantDraeger Medical Systems, Inc.
Decision Date2023-10-17
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Infinity CentralStation Wide, Infinity M300, Infinity M300+ 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 2023-10-17 under 510(k) number K231477. 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 CentralStation Wide, Infinity M300, Infinity M300+?

Infinity CentralStation Wide, Infinity M300, Infinity M300+ is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K231477.

When did Infinity CentralStation Wide, Infinity M300, Infinity M300+ receive FDA 510(k) clearance?

Infinity CentralStation Wide, Infinity M300, Infinity M300+ received FDA 510(k) clearance on 2023-10-17, under 510(k) number K231477.

Who is the listed applicant for Infinity CentralStation Wide, Infinity M300, Infinity M300+?

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 CentralStation Wide, Infinity M300, Infinity M300+?

The FDA product code for Infinity CentralStation Wide, Infinity M300, Infinity M300+ is MHX.

Other records listing Draeger Medical Systems, Inc. as applicant

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Related Devices (Code: 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.

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