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FDA 510(k)

Equinox Advantage

K-Number: K173205 · 2018-08-29

ApplicantO-Two Medical Technologies, Inc.
Decision Date2018-08-29
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Equinox Advantage is a medical device manufactured by O-Two Medical Technologies, Inc.. It received FDA 510(k) clearance on 2018-08-29 under approval number K173205. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Equinox Advantage?

Equinox Advantage is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by O-Two Medical Technologies, Inc.. The 510(k) number is K173205.

When was Equinox Advantage approved by the FDA?

Equinox Advantage received FDA 510(k) clearance on 2018-08-29, under approval number K173205.

What company makes Equinox Advantage?

Equinox Advantage is manufactured by O-Two Medical Technologies, Inc..

What is the FDA product code for Equinox Advantage?

The FDA product code for Equinox Advantage is BZR.

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Official Source

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