C.A.R.E. Appliance (DNA, mRNA, mmRNA)
K-Number: K230947 · 2023-11-28
ApplicantVivos Therapeutics, Inc.
Decision Date2023-11-28
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
C.A.R.E. Appliance (DNA, mRNA, mmRNA) is a medical device manufactured by Vivos Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-11-28 under approval number K230947. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the C.A.R.E. Appliance (DNA, mRNA, mmRNA)?
C.A.R.E. Appliance (DNA, mRNA, mmRNA) is a medical device that received FDA 510(k) clearance on 2023-11-28. It is manufactured by Vivos Therapeutics, Inc.. The 510(k) number is K230947.
When was C.A.R.E. Appliance (DNA, mRNA, mmRNA) approved by the FDA?
C.A.R.E. Appliance (DNA, mRNA, mmRNA) received FDA 510(k) clearance on 2023-11-28, under approval number K230947.
What company makes C.A.R.E. Appliance (DNA, mRNA, mmRNA)?
C.A.R.E. Appliance (DNA, mRNA, mmRNA) is manufactured by Vivos Therapeutics, Inc..
What is the FDA product code for C.A.R.E. Appliance (DNA, mRNA, mmRNA)?
The FDA product code for C.A.R.E. Appliance (DNA, mRNA, mmRNA) is LRK.
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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.