510(k) K993637 ยท DQA Oximeter
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
| Applicant | Nellcor Puritan Bennett, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Nov 24, 1999 |
| Received | Oct 28, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993637
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand Pulse Oximeter, model N-395,
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.