510(k) K073682 ยท MNR Ventilatory Effort Recorder
EMBLETTA GOLD
| Applicant | Embla Systems, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Aug 8, 2008 |
| Received | Dec 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073682
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2013 | Embla System Llc embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder).
The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis Terminated |
MNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.