WINDSURFER
FDA 510(k) clearance K050561 · decided 2005-05-04
Clearance details
- K-number
- K050561
- Device name
- WINDSURFER
- Applicant
- Medcon , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-03
- Decision date
- 2005-05-04
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Efrat, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Horizon Cardiology Hemo. Version 12.2. recall (Z-0127-2025) | CHANGE HEALTHCARE CANADA COMPANY | 2024-10-17 |
| Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 10 recall (Z-1974-2010) | McKesson Provider Technologies - Medical Imaging Group | 2010-07-09 |
| Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for recall (Z-1899-2010) | McKesson Provider Technologies - Medical Imaging Group | 2010-06-24 |
| Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~1 recall (Z-0710-2008) | McKesson Provider Technologies | 2008-02-05 |