510(k) K904039 ยท DQA Oximeter
REFLECTANCE SENSOR (RS-10)
| Applicant | Nellcor, Inc., Hayward CA, US |
| Decision | Substantially Equivalent, Dec 27, 1990 |
| Received | Sep 4, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904039
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2016 | Covidien LLC Covidien Nellcor SpO2 Forehead Sensor
Item Code: RS10;
The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rat Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.