SPACELABS HEALTHCARE TELEMETRY RECEIVER
FDA 510(k) clearance K141156 · decided 2014-09-09
Clearance details
- K-number
- K141156
- Device name
- SPACELABS HEALTHCARE TELEMETRY RECEIVER
- Applicant
- Spacelabs Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2014-05-05
- Decision date
- 2014-09-09
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nederland, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitorin recall (Z-0809-2025) | Spacelabs Healthcare, Inc. | 2025-01-07 |
| Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring syste recall (Z-0810-2025) | Spacelabs Healthcare, Inc. | 2025-01-07 |
| Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiol recall (Z-0532-2018) | Spacelabs Healthcare Inc | 2018-01-25 |
| Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receiv recall (Z-2886-2016) | Spacelabs Healthcare Inc | 2016-09-26 |