510(k) K953697 ยท BZD Ventilator, Non-Continuous (Respirator)
THE IMS DPAP MASK, IMS MODEL NUMBER 82000
| Applicant | Sleepnet Corporation, Manchester NH, US |
| Decision | Substantially Equivalent, Jun 13, 1996 |
| Received | Aug 8, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953697
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.