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FDA 510(k)

Reflow System Mini and ReFlow Mini Flusher

K-Number: K223603 · 2022-12-29

ApplicantAnuncia Medical, Inc.
Decision Date2022-12-29
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Reflow System Mini and ReFlow Mini Flusher is a medical device manufactured by Anuncia Medical, Inc.. It received FDA 510(k) clearance on 2022-12-29 under approval number K223603. 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 and ReFlow Mini Flusher?

Reflow System Mini and ReFlow Mini Flusher is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Anuncia Medical, Inc.. The 510(k) number is K223603.

When was Reflow System Mini and ReFlow Mini Flusher approved by the FDA?

Reflow System Mini and ReFlow Mini Flusher received FDA 510(k) clearance on 2022-12-29, under approval number K223603.

What company makes Reflow System Mini and ReFlow Mini Flusher?

Reflow System Mini and ReFlow Mini Flusher is manufactured by Anuncia Medical, Inc..

What is the FDA product code for Reflow System Mini and ReFlow Mini Flusher?

The FDA product code for Reflow System Mini and ReFlow Mini Flusher is JXG.

Other Devices by Anuncia Medical, Inc.

K221918ReFlow System Mini

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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.

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