The following data is part of a premarket notification filed by O-two Medical Technologies, Inc. with the FDA for Equinox Relieve.
| Device ID | K113687 |
| 510k Number | K113687 |
| Device Name: | EQUINOX RELIEVE |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, CA L5s 1c8 |
| Contact | David Zhang |
| Correspondent | David Zhang O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, CA L5s 1c8 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-15 |
| Decision Date | 2012-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540195040014 | K113687 | 000 |
| 07540195040045 | K113687 | 000 |
| 17540195040073 | K113687 | 000 |