510(k) K112167 ยท BZD Ventilator, Non-Continuous (Respirator)
SOYALA SILKGEL FULL FACE MASK
| Applicant | Weinmann Gerate Fur Medizin GmbH + Co. KG, Hamburg, DE |
| Decision | Substantially Equivalent, Nov 16, 2011 |
| Received | Jul 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112167
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.