| Device Classification Name |
transducer, ultrasonic, diagnostic |
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|---|---|---|---|---|---|
| 510(k) Number | K111021 | ||||
| Device Name | CUBESCAN / BIOCON-700 | ||||
| Applicant |
|
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| Applicant Contact | seungtai kim | ||||
| Regulation Number | 892.1570 | ||||
| Classification Product Code |
|
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| Subsequent Product Code |
|
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| Date Received | 04/12/2011 | ||||
| Decision Date | 04/27/2011 | ||||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Radiology |
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| 510k Review Panel |
Radiology |
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| summary |
summary |
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| Type | Traditional | ||||
| Reviewed by Third Party | Yes | ||||
| Combination Product |
No |