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FDA 510(k)

Isolette 8000 plus

K-Number: K172154 · 2018-04-19

ApplicantDraeger Medical Sytems, Inc.
Decision Date2018-04-19
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Isolette 8000 plus is a medical device manufactured by Draeger Medical Sytems, Inc.. It received FDA 510(k) clearance on 2018-04-19 under approval number K172154. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Isolette 8000 plus?

Isolette 8000 plus is a medical device that received FDA 510(k) clearance on 2018-04-19. It is manufactured by Draeger Medical Sytems, Inc.. The 510(k) number is K172154.

When was Isolette 8000 plus approved by the FDA?

Isolette 8000 plus received FDA 510(k) clearance on 2018-04-19, under approval number K172154.

What company makes Isolette 8000 plus?

Isolette 8000 plus is manufactured by Draeger Medical Sytems, Inc..

What is the FDA product code for Isolette 8000 plus?

The FDA product code for Isolette 8000 plus is FMZ.

Related Devices (Code: FMZ)

K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company K162821Babyleo TN500Draegerwerk AG & CO Kgaa K182977Isolette 8000 PlusDraeger Medical Systems, Inc. K190494Infant IncubatorNingbo David Medical Device Co., Ltd. K182859Babyleo TN500Dragerwerk AG & CO Kgaa K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.

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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