510(k) K042745 ยท MNR Ventilatory Effort Recorder
LIFESCREEN APNEA
| Applicant | Del Mar Reynolds Medical, Inc., Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Jan 19, 2005 |
| Received | Oct 4, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042745
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Del Mar Reynolds Medical, Ltd. Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31.
Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea Terminated |
MNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.