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 |