510(k) K122146 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
XHIBIT CENTRAL STATION, MODEL 96102
| Applicant | Spacelabs Healthcare, Nederland CO, US |
| Decision | Substantially Equivalent, Apr 22, 2013 |
| Received | Jul 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Spacelabs Healthcare, Inc. Brand Name: Xhibit
Product Name: Xhibit Central Station
Model/Catalog Number: 96102
Software Version: N/A
Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Open, Classified |
MHX | None listed |
| Aug 30, 2019 | Spacelabs Healthcare, Inc. Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelab Terminated |
MHX | None listed |
| Nov 2, 2016 | Spacelabs Healthcare Inc Xhibit Central Station, Model 96102.
Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthc Terminated |
MHX | None listed |
| Sep 26, 2016 | Spacelabs Healthcare Inc Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2.
Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Terminated |
MHX | None listed |
| Feb 26, 2016 | Spacelabs Healthcare Inc Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient mo Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.