510(k) K002159 ยท MNR Ventilatory Effort Recorder
SNORE SAT RECORDER, MODEL SS41
| Applicant | Sagatech Electronics, Inc., Calgary, Alberta, CA |
| Decision | Substantially Equivalent, Jun 28, 2002 |
| Received | Jul 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2013 | SagaTech Electronics, Inc. Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder)
To be used to gather heart rate and blood oxygen data during a sleep study. Terminated |
MNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.