ClearanceBrief
510(k) K141156 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

SPACELABS HEALTHCARE TELEMETRY RECEIVER

ApplicantSpacelabs Healthcare, Nederland CO, US
DecisionSubstantially Equivalent, Sep 9, 2014
ReceivedMay 5, 2014
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K141156

DateFirm and productCodeLinked 510(k)
Jan 7, 2025Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Open, Classified		 MHXNone listed
Jan 7, 2025Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Open, Classified		 MHXNone listed
May 31, 2022Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model: 96280
Open, Classified		 MHXNone listed
Jan 25, 2018Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Mod
Terminated		 MSXNone listed
Sep 26, 2016Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Terminated		 MHXNone listed
Mar 28, 2016Spacelabs Healthcare Inc
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Terminated		 MHXNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.