X-PLO2R
K-Number: K203086 · 2021-03-02
ApplicantBelluscura, LLC
Decision Date2021-03-02
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
X-PLO2R is a medical device manufactured by Belluscura, LLC. It received FDA 510(k) clearance on 2021-03-02 under approval number K203086. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the X-PLO2R?
X-PLO2R is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Belluscura, LLC. The 510(k) number is K203086.
When was X-PLO2R approved by the FDA?
X-PLO2R received FDA 510(k) clearance on 2021-03-02, under approval number K203086.
What company makes X-PLO2R?
X-PLO2R is manufactured by Belluscura, LLC.
What is the FDA product code for X-PLO2R?
The FDA product code for X-PLO2R is CAW.
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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.