510(k) K113687 ยท BZR Mixer, Breathing Gases, Anesthesia Inhalation
EQUINOX RELIEVE
| Applicant | O-Two Medical Technologies, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Apr 30, 2012 |
| Received | Dec 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113687
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2018 | CAREstream Medical LLC CAREstream ProNox Nitrous Oxide Delivery System labeled as the following:
a. CMI-0100 PNX, Pro-Nox Mixer - Canadian;
b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxi Terminated |
BZR | None listed |
| May 14, 2018 | O-Two Medical Technologies, Inc. O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System
Model#: 01EQ1000 Terminated |
BZR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.