510(k) K150685 ยท BZD Ventilator, Non-Continuous (Respirator)
Skynector CPAP Mask
| Applicant | Sky Wise Medical Instrument (Shen Zhen) Co., Ltd., Shenzhen, Guang Dong, CN |
| Decision | Substantially Equivalent, Aug 24, 2015 |
| Received | Mar 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150685
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.