510(k) K970098 ยท DQA Oximeter
E100 SERIES SPO2 SENSORS
| Applicant | Epic Medical Equipment Services, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Apr 30, 1998 |
| Received | Jan 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970098
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2008 | Kentec Medical Inc Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.