510(k) K061653 ยท BZD Ventilator, Non-Continuous (Respirator)
SOYALA FULL FACE MASK
| Applicant | Weinmann Gerate Fur Medizin GmbH + Co. KG, Hamburg, DE |
| Decision | Substantially Equivalent, Nov 9, 2006 |
| Received | Jun 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061653
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.