FDA 510(k)

ADAPT, MODEL AX-03SN

K-Number: K100954 · 2011-02-25

Decision Date2011-02-25

Product CodeOUM

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ADAPT, MODEL AX-03SN is the device name listed in this FDA 510(k) record. The listed applicant is Apeliotus Vision Science, Inc.. It received FDA 510(k) clearance on 2011-02-25 under 510(k) number K100954. The device is classified under product code OUM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPT, MODEL AX-03SN?

ADAPT, MODEL AX-03SN is a medical device that received FDA 510(k) clearance on 2011-02-25. The listed applicant is Apeliotus Vision Science, Inc.. The 510(k) number is K100954.

When did ADAPT, MODEL AX-03SN receive FDA 510(k) clearance?

ADAPT, MODEL AX-03SN received FDA 510(k) clearance on 2011-02-25, under 510(k) number K100954.

Who is the listed applicant for ADAPT, MODEL AX-03SN?

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

What is the FDA product code for ADAPT, MODEL AX-03SN?

The FDA product code for ADAPT, MODEL AX-03SN is OUM.

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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.