ReFlow System Mini
K-Number: K221918 · 2022-09-29
ApplicantAnuncia Medical, Inc.
Decision Date2022-09-29
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ReFlow System Mini is a medical device manufactured by Anuncia Medical, Inc.. It received FDA 510(k) clearance on 2022-09-29 under approval number K221918. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ReFlow System Mini?
ReFlow System Mini is a medical device that received FDA 510(k) clearance on 2022-09-29. It is manufactured by Anuncia Medical, Inc.. The 510(k) number is K221918.
When was ReFlow System Mini approved by the FDA?
ReFlow System Mini received FDA 510(k) clearance on 2022-09-29, under approval number K221918.
What company makes ReFlow System Mini?
ReFlow System Mini is manufactured by Anuncia Medical, Inc..
What is the FDA product code for ReFlow System Mini?
The FDA product code for ReFlow System Mini is JXG.
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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.