510(k) K132402 ยท DQA Oximeter
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
| Applicant | Nonin Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 21, 2014 |
| Received | Aug 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2014 | Nonin Medical, Inc SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.