Isolette 8000 Plus
K-Number: K182977 · 2018-11-21
ApplicantDraeger Medical Systems, Inc.
Decision Date2018-11-21
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Isolette 8000 Plus is a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-11-21 under approval number K182977. 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 2018-11-21. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K182977.
When was Isolette 8000 Plus approved by the FDA?
Isolette 8000 Plus received FDA 510(k) clearance on 2018-11-21, under approval number K182977.
What company makes Isolette 8000 Plus?
Isolette 8000 Plus is manufactured by Draeger Medical Systems, Inc..
What is the FDA product code for Isolette 8000 Plus?
The FDA product code for Isolette 8000 Plus is FMZ.
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.