510(k) K013792 ยท DQA Oximeter
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
| Applicant | Masimo Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 11, 2001 |
| Received | Nov 14, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013792
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.