510(k) K971273 ยท DQA Oximeter
INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
| Applicant | Bio-Tek Instruments, Inc., Winooski VT, US |
| Decision | Substantially Equivalent, Oct 8, 1997 |
| Received | Apr 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971273
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.