510(k) K112962 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
| Applicant | Spacelabs Medical, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Nov 2, 2011 |
| Received | Oct 5, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0895-01
Software Version: N/A
Product Description: 6 foot DVI-I to DVI-I male/male displ Open, Classified |
MHX | None listed |
| Oct 16, 2025 | Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0895-12
Software Version: N/A
Product Description: 12 foot DVI-I to DVI-I male/male disp Open, Classified |
MHX | None listed |
| Oct 16, 2025 | Spacelabs Healthcare, Inc. Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0893-01
Software Version: N/A
Product Description: 16 inch DVI-I to DVI-I male/male disp Open, Classified |
MHX | None listed |
| Feb 24, 2015 | Spacelabs Healthcare Inc Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, an Terminated |
MHX | None listed |
| Nov 5, 2012 | Spacelabs Healthcare, Llc The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal -- Terminated |
MHX | None listed |
| Jul 16, 2012 | Spacelabs Healthcare, Llc Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms.
The Spacelabs Healthcare Xprezzon Bedside Monitor is Terminated |
MHX | None listed |
| Jun 5, 2012 | Spacelabs Healthcare, Llc Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393.
The Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parame Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.