510(k) K963698 ยท DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
| Applicant | International Biophysics Corp., Austin TX, US |
| Decision | Substantially Equivalent, Mar 20, 1997 |
| Received | Sep 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963698
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.