| Device Classification Name |
coil, magnetic resonance, specialty |
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|---|---|---|---|---|---|
| 510(k) Number | K111259 | ||||
| Device Name | SV DBS VRAIN ARRAY | ||||
| Applicant |
|
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| Applicant Contact | helmut keidi | ||||
| Correspondent |
|
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| Correspodent Contact | helmut keidi | ||||
| Regulation Number | 892.1000 | ||||
| Classification Product Code |
|
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| Date Received | 05/04/2011 | ||||
| Decision Date | 07/05/2011 | ||||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Radiology |
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| 510k Review Panel |
Radiology |
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| statement |
statement |
||||
| Type | Traditional | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |