SPACELABS MULTI-PARAMETER MODULE
FDA 510(k) clearance K103142 · decided 2011-03-03
Clearance details
- K-number
- K103142
- Device name
- SPACELABS MULTI-PARAMETER MODULE
- Applicant
- Spacelabs Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-25
- Decision date
- 2011-03-03
- Days to decision
- 129 days
- Clearance type
- Special
- Product code
- DSI
- 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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