510(k) K171423 ยท DQA Oximeter
Nasal Alar SpO2 Sensor
| Applicant | Xhale, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 27, 2017 |
| Received | May 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171423
| 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.