510(k) K081335 ยท BZR Mixer, Breathing Gases, Anesthesia Inhalation
TENACORE OXYGEN BLENDER, MODEL TB-2000
| Applicant | Tenacore Holdings, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Nov 14, 2008 |
| Received | May 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081335
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.