510(k) K012891 ยท DQA Oximeter
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
| Applicant | Nellcor Puritan Bennett, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Mar 7, 2002 |
| Received | Aug 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012891
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand OxiMax Pulse Oximeter, model number N-595
Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A. Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.