510(k) K823273 ยท DTZ Oxygenator, Cardiopulmonary Bypass
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
| Applicant | Bentley Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 5, 1983 |
| Received | Nov 2, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823273
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.