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FDA 510(k)

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.

K-Number: K221803 · 2022-07-18

ApplicantSedecal., Sa.
Decision Date2022-07-18
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. is a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2022-07-18 under approval number K221803. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.?

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. is a medical device that received FDA 510(k) clearance on 2022-07-18. It is manufactured by Sedecal., Sa.. The 510(k) number is K221803.

When was PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. approved by the FDA?

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. received FDA 510(k) clearance on 2022-07-18, under approval number K221803.

What company makes PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.?

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. is manufactured by Sedecal., Sa..

What is the FDA product code for PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.?

The FDA product code for PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. is IZL.

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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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