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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 a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-10-17 under approval 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. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K231477.

When was Infinity CentralStation Wide, Infinity M300, Infinity M300+ approved by the FDA?

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

What company makes Infinity CentralStation Wide, Infinity M300, Infinity M300+?

Infinity CentralStation Wide, Infinity M300, Infinity M300+ is manufactured by Draeger Medical Systems, Inc..

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.

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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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