510(k) K131111 ยท DQA Oximeter
IHEALTH FINGERTIP PULSE OXIMETER
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Sep 11, 2013 |
| Received | Apr 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131111
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.