510(k) K002763 ยท BZD Ventilator, Non-Continuous (Respirator)
REMREST
| Applicant | Medical Industries America, Inc., Adel IA, US |
| Decision | Substantially Equivalent, May 4, 2001 |
| Received | Sep 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2004 | Medical Industries America Inc RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA. Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.