AViTA Pulse Oximeter
K-Number: K223399 · 2024-05-20
ApplicantAvita Corporation
Decision Date2024-05-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AViTA Pulse Oximeter is a medical device manufactured by Avita Corporation. It received FDA 510(k) clearance on 2024-05-20 under approval number K223399. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AViTA Pulse Oximeter?
AViTA Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2024-05-20. It is manufactured by Avita Corporation. The 510(k) number is K223399.
When was AViTA Pulse Oximeter approved by the FDA?
AViTA Pulse Oximeter received FDA 510(k) clearance on 2024-05-20, under approval number K223399.
What company makes AViTA Pulse Oximeter?
AViTA Pulse Oximeter is manufactured by Avita Corporation.
What is the FDA product code for AViTA Pulse Oximeter?
The FDA product code for AViTA Pulse Oximeter is DQA.
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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.