Equinox Advantage

Mixer, Breathing Gases, Anesthesia Inhalation

O-Two Medical Technologies Inc.

The following data is part of a premarket notification filed by O-two Medical Technologies Inc. with the FDA for Equinox Advantage.

Pre-market Notification Details

Device IDK173205
510k NumberK173205
Device Name:Equinox Advantage
ClassificationMixer, Breathing Gases, Anesthesia Inhalation
Applicant O-Two Medical Technologies Inc. 45A Armthorpe Road Brampton,  CA L6t 5m4
ContactDavid Zhang
CorrespondentDavid Zhang
O-Two Medical Technologies Inc. 45A Armthorpe Road Brampton,  CA L6t 5m4
Product CodeBZR  
CFR Regulation Number868.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-02
Decision Date2018-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07540195040052 K173205 000

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