510(k) K103142 ยท DSI Detector And Alarm, Arrhythmia
SPACELABS MULTI-PARAMETER MODULE
| Applicant | Spacelabs Healthcare, Inc., Nederland CO, US |
| Decision | Substantially Equivalent, Mar 3, 2011 |
| Received | Oct 25, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patien Open, Classified |
MHX | None listed |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Open, Classified |
MHX | None listed |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Pati Open, Classified |
MHX | None listed |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physio Open, Classified |
MHX | None listed |
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia D Open, Classified |
MHX | None listed |
| May 1, 2026 | Spacelabs Healthcare, Inc. Brand Name: Spacelabs Ultraview SL Command Module
Product Name: SL Command Module
Model/Catalog Number: 91496
Software Version: N/A
Product Description: The Command Module (91496) is the core of the S Open, Classified |
DSI | None listed |
| Apr 7, 2026 | Spacelabs Healthcare, Inc. Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor Open, Classified |
DSI | None listed |
| May 3, 2023 | Spacelabs Healthcare, Inc. Ultraview SL (UVSL) Command Module, Model 91496 Open, Classified |
DSI | None listed |
| Aug 4, 2016 | Spacelabs Healthcare Inc 91496 Ultraview SL Command Module, Options A, B, C, and I.
Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP.
Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 Terminated |
DSI | None listed |
| May 4, 2015 | Spacelabs Healthcare Inc Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02.
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acqu Terminated |
DSI | None listed |
| Apr 28, 2015 | Spacelabs Healthcare Inc Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option.
Product Usage:
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PC Terminated |
DSI | None listed |
| Jun 3, 2014 | Spacelabs Healthcare Inc Spacelabs Medical Ultraview SL Command Module, Model 91496.
Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and Terminated |
DSI | None listed |
| Jan 17, 2012 | Spacelabs Healthcare, Llc Spacelabs Medical Ultraview SL Command Module, Model 91496.
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process va Terminated |
DSI | None listed |
| Jan 11, 2012 | Spacelabs Healthcare, Llc Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.