510(k) K010413 ยท DQA Oximeter
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
| Applicant | Konica Minolta Sensing, Inc., Bailey CO, US |
| Decision | Substantially Equivalent, Aug 2, 2001 |
| Received | Feb 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Minolta Corp Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 Terminated |
DQA | None listed |
| Jul 20, 2004 | Minolta Corp Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accur Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.