510(k) K061256 ยท NPF Monitor, Apnea, Home Use
SMARTMONITOR 2PS
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Aug 2, 2006 |
| Received | May 4, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K061256
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2017 | Circadiance LLC SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE.
Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients. Terminated |
NPE | None listed |
| Jun 13, 2014 | Childrens Medical Ventures Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. Terminated |
NPF | None listed |
| Apr 24, 2008 | Respironics, Inc. APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Sma Terminated |
NPF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.