SAFIRA
K-Number: K230083 · 2023-10-31
ApplicantMedovate Limited
Decision Date2023-10-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SAFIRA is a medical device manufactured by Medovate Limited. It received FDA 510(k) clearance on 2023-10-31 under approval number K230083. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SAFIRA?
SAFIRA is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Medovate Limited. The 510(k) number is K230083.
When was SAFIRA approved by the FDA?
SAFIRA received FDA 510(k) clearance on 2023-10-31, under approval number K230083.
What company makes SAFIRA?
SAFIRA is manufactured by Medovate Limited.
What is the FDA product code for SAFIRA?
The FDA product code for SAFIRA is FRN.
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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.