SONARA; SONARA/TEK
FDA 510(k) clearance K060421 · decided 2006-11-03
Clearance details
- K-number
- K060421
- Device name
- SONARA; SONARA/TEK
- Applicant
- Viasys Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-17
- Decision date
- 2006-11-03
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Conshohocken, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of recall (Z-0998-2009) | Cardinal Health, Inc | 2009-04-07 |
| Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of recall (Z-0999-2009) | Cardinal Health, Inc | 2009-04-07 |