510(k) K120616 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
| Applicant | Spacelabs Medical, Inc., Nederland CO, US |
| Decision | Substantially Equivalent, Mar 29, 2012 |
| Received | Feb 29, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120616
| 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 |
| May 13, 2015 | Spacelabs Healthcare Inc Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports i Terminated |
MHX | None listed |
| Feb 24, 2015 | Spacelabs Healthcare Inc Spacelabs Healthcare qube Compact Monitor, Model 91390.
The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated b Terminated |
MHX | None listed |
| Jun 23, 2014 | Spacelabs Healthcare Inc Spacelabs Healthcare Qube Compact Monitor, Model 91390.
Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors vi Terminated |
MHX | None listed |
| Nov 18, 2013 | Spacelabs Healthcare, Llc Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms.
The qube is intended for use under the direct supervision of a licensed h Terminated |
MHX | None listed |
| Nov 8, 2013 | Spacelabs Healthcare, Llc Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms. Terminated |
MHX | None listed |
| Nov 20, 2012 | Spacelabs Healthcare, Llc qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD displa Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.