510(k) K063268 ยท BZD Ventilator, Non-Continuous (Respirator)
CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
| Applicant | Hsiner Co., Ltd., Temecula CA, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Oct 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2018 | Compass Health Brands (Corporate Office) CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L
Product Usage:
A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The rep Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.