The following data is part of a premarket notification filed by O-two Medical Technologies Inc. with the FDA for Equinox Advantage.
Device ID | K173205 |
510k Number | K173205 |
Device Name: | Equinox Advantage |
Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
Applicant | O-Two Medical Technologies Inc. 45A Armthorpe Road Brampton, CA L6t 5m4 |
Contact | David Zhang |
Correspondent | David Zhang O-Two Medical Technologies Inc. 45A Armthorpe Road Brampton, CA L6t 5m4 |
Product Code | BZR |
CFR Regulation Number | 868.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-02 |
Decision Date | 2018-08-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07540195040052 | K173205 | 000 |