SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
FDA 510(k) clearance K972502 · decided 1998-05-28
Clearance details
- K-number
- K972502
- Device name
- SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
- Applicant
- Spacelabs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-03
- Decision date
- 1998-05-28
- Days to decision
- 329 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 |
|---|---|---|
| Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear pl recall (Z-2314-2008) | Spacelabs Healthcare, Incorporated | 2008-09-20 |
| Ultraview SL Command Module, Model 90496 The product is intended for use with the Patient recall (Z-2342-2008) | Spacelabs Healthcare, Incorporated | 2008-09-19 |
| Ultraview SL Command Module, Model 91496 The product is intended for use with the Patient recall (Z-2343-2008) | Spacelabs Healthcare, Incorporated | 2008-09-19 |