510(k) K972837 ยท DQA Oximeter
NPB-290 PULSE OXIMETER (NPB-290)
| Applicant | Nellcor Puritan Bennett, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Oct 21, 1997 |
| Received | Jul 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart,
Made in Ireland; Distributed by 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.