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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 the device name listed in this FDA 510(k) record. The listed applicant is Anuncia Medical, Inc.. It received FDA 510(k) clearance on 2022-12-29 under 510(k) 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. The listed applicant is Anuncia Medical, Inc.. The 510(k) number is K223603.

When did Reflow System Mini and ReFlow Mini Flusher receive FDA 510(k) clearance?

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

Who is the listed applicant for Reflow System Mini and ReFlow Mini Flusher?

The FDA 510(k) record lists Anuncia Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Anuncia Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221918ReFlow System Mini

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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