510(k) K102120 ยท CBK Ventilator, Continuous, Facility Use
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
| Applicant | Hsiner Co., Ltd., Temecula CA, US |
| Decision | Substantially Equivalent, Aug 12, 2011 |
| Received | Jul 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102120
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.