FDA 510(k)

Equinox Advantage

Numéro K : K173205 · 2018-08-29

DemandeurO-Two Medical Technologies, Inc.

Date de décision2018-08-29

Code produitBZR

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

What is the Equinox Advantage?

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

When did Equinox Advantage receive FDA 510(k) clearance?

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

Who is the listed applicant for Equinox Advantage?

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

What is the FDA product code for Equinox Advantage?

The FDA product code for Equinox Advantage is BZR.

Essais cliniques associés

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Source officielle

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