510(k) K011597 ยท FLS Monitor, Apnea, Facility Use
SMARTMONITOR 2, MODEL 4000
| Applicant | Respironics Georgia, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Jan 11, 2002 |
| Received | May 24, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K011597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2009 | Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor.
The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor det Terminated |
FLS | None listed |
| Apr 24, 2008 | Respironics, Inc. Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
FLS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.