XHIBIT CENTRAL STATION, MODEL 96102
FDA 510(k) clearance K122146 · decided 2013-04-22
Clearance details
- K-number
- K122146
- Device name
- XHIBIT CENTRAL STATION, MODEL 96102
- Applicant
- Spacelabs Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2012-07-19
- Decision date
- 2013-04-22
- Days to decision
- 277 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 |
|---|---|---|
| Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Softwa recall (Z-2916-2026) | Spacelabs Healthcare, Inc. | 2026-08-07 |
| Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central mo recall (Z-0332-2017) | Spacelabs Healthcare Inc | 2016-11-02 |
| Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry recall (Z-2885-2016) | Spacelabs Healthcare Inc | 2016-09-26 |