510(k) K143216 ยท DQA Oximeter
Assurance Alar / Nasal SpO2 Sensor
| Applicant | Xhale, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 17, 2015 |
| Received | Nov 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2019 | Xhale Assurance, Inc. Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only
Product Usage:
The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of function Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.