Vit Kit- Freeze NX and Vit Kit- Warm NX
K-Number: K190152 · 2019-06-21
ApplicantFujifilm Irvine Scientific, Inc.
Decision Date2019-06-21
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Vit Kit- Freeze NX and Vit Kit- Warm NX is a medical device manufactured by Fujifilm Irvine Scientific, Inc.. It received FDA 510(k) clearance on 2019-06-21 under approval number K190152. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vit Kit- Freeze NX and Vit Kit- Warm NX?
Vit Kit- Freeze NX and Vit Kit- Warm NX is a medical device that received FDA 510(k) clearance on 2019-06-21. It is manufactured by Fujifilm Irvine Scientific, Inc.. The 510(k) number is K190152.
When was Vit Kit- Freeze NX and Vit Kit- Warm NX approved by the FDA?
Vit Kit- Freeze NX and Vit Kit- Warm NX received FDA 510(k) clearance on 2019-06-21, under approval number K190152.
What company makes Vit Kit- Freeze NX and Vit Kit- Warm NX?
Vit Kit- Freeze NX and Vit Kit- Warm NX is manufactured by Fujifilm Irvine Scientific, Inc..
What is the FDA product code for Vit Kit- Freeze NX and Vit Kit- Warm NX?
The FDA product code for Vit Kit- Freeze NX and Vit Kit- Warm NX is MQL.
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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.