510(k) K231652 ยท DTZ Oxygenator, Cardiopulmonary Bypass
D100 KIDS; D101 KIDS
| Applicant | Sorin Group Italia S.R.L., Mirandola (Modena), IT |
| Decision | Substantially Equivalent, Nov 16, 2023 |
| Received | Jun 6, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231652
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.