SPACELABS HEALTHCARE TELEMETRY RECEIVER— 510(k) K141156
Substantially EquivalentSpacelabs Healthcare
FDA 510(k) clearance K141156 for SPACELABS HEALTHCARE TELEMETRY RECEIVER, Substantially Equivalent on 2014-09-09. Applicant: Spacelabs Healthcare. Device class: 2.
Clearance details
- Applicant
- Spacelabs Healthcare
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nederland, CO, US
Recent devices under product code MHX
view allMore clearances from Spacelabs Healthcare
view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K141156
K-number listed on FDA's recall record- Z-0809-2025 — Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
- Z-0810-2025 — Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Z-1513-2022 — Xhibit Telemetry Receiver, Model: 96280
- Z-0532-2018 — Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
- Z-2886-2016 — 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.
- Z-1502-2016 — The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141156.
Data sourced from openFDA. This site is unofficial and independent of the FDA.