SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
FDA 510(k) clearance K932724 · decided 1993-11-05
Clearance details
- K-number
- K932724
- Device name
- SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
- Applicant
- Spacelabs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-07
- Decision date
- 1993-11-05
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- DXJ
- Device class
- 2
- Regulation number
- 870.2450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transisto recall (Z-0620-2011) | Spacelabs Healthcare, Llc | 2010-12-14 |
| The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by recall (Z-0288-2011) | Spacelabs Healthcare, Incorporated | 2010-11-02 |
| Ultraview Universal Clinical Workstation System Model 90385. recall (Z-0422-05) | Spacelabs Medical Incorporated | 2005-01-25 |
| Spacelabs flat panel monitor, Model 91415-A recall (Z-0269-04) | Datex-Ohmeda, Inc. | 2004-07-20 |