510(k) K121480 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
ARIATELE TELEMETRY TRANSMITTER (96281)
| Applicant | Spacelabs Healthcare, Nederland CO, US |
| Decision | Substantially Equivalent, Jun 6, 2012 |
| Received | May 18, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121480
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2014 | Spacelabs Healthcare Inc ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment. Terminated |
MHX | None listed |
| Jan 30, 2014 | Spacelabs Healthcare, Llc ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C.
Model 96281 is intended for use with either adult or neonatal patient
populations in a hospital environment. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.