510(k) K123581 ยท DQA Oximeter
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
| Applicant | Covidien, Formerly Nellcor Puritan Bennett, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, May 9, 2013 |
| Received | Nov 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2015 | Covidien LP (formerly Nellcor Puritan Bennett Inc.) OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
| Jul 27, 2015 | Covidien LP (formerly Nellcor Puritan Bennett Inc.) OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.