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 |