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FDA 510(k)

AXS-590 SERIES

K-Number: K091650 · 2009-11-24

ApplicantSwr International, Ltd.
Decision Date2009-11-24
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AXS-590 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Swr International, Ltd.. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K091650. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXS-590 SERIES?

AXS-590 SERIES is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Swr International, Ltd.. The 510(k) number is K091650.

When did AXS-590 SERIES receive FDA 510(k) clearance?

AXS-590 SERIES received FDA 510(k) clearance on 2009-11-24, under 510(k) number K091650.

Who is the listed applicant for AXS-590 SERIES?

The FDA 510(k) record lists Swr International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXS-590 SERIES?

The FDA product code for AXS-590 SERIES is CAW.

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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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