SPACELABS PATHFINDER SL HOLTER ANALYZER
FDA 510(k) clearance K110001 · decided 2011-06-14
Clearance details
- K-number
- K110001
- Device name
- SPACELABS PATHFINDER SL HOLTER ANALYZER
- Applicant
- Spacelabs Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-03
- Decision date
- 2011-06-14
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- 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 |
|---|---|---|
| The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthca recall (Z-1831-2012) | Spacelabs Healthcare, Llc | 2012-06-20 |