Spirobank Oxi
K-Number: K230501 · 2023-12-15
Decision Date2023-12-15
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Spirobank Oxi is a medical device manufactured by Mir Medical International Research USA. It received FDA 510(k) clearance on 2023-12-15 under approval number K230501. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Spirobank Oxi?
Spirobank Oxi is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Mir Medical International Research USA. The 510(k) number is K230501.
When was Spirobank Oxi approved by the FDA?
Spirobank Oxi received FDA 510(k) clearance on 2023-12-15, under approval number K230501.
What company makes Spirobank Oxi?
Spirobank Oxi is manufactured by Mir Medical International Research USA.
What is the FDA product code for Spirobank Oxi?
The FDA product code for Spirobank Oxi is BZG.
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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.