SPACELABS MEDICAL PCIS PATIENT MONITORS
FDA 510(k) clearance K972282 · decided 1997-09-25
Clearance details
- K-number
- K972282
- Device name
- SPACELABS MEDICAL PCIS PATIENT MONITORS
- Applicant
- Spacelabs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-18
- Decision date
- 1997-09-25
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- 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 |
|---|---|---|
| Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with t recall (Z-3036-2011) | Spacelabs Healthcare, Llc | 2011-08-18 |
| Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively recall (Z-0647-2010) | Spacelabs Healthcare, Incorporated | 2010-01-19 |
| Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors passiv recall (Z-0648-2010) | Spacelabs Healthcare, Incorporated | 2010-01-19 |
| Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively recall (Z-0649-2010) | Spacelabs Healthcare, Incorporated | 2010-01-19 |