Device Classification Name |
system, imaging, pulsed doppler, ultrasonic |
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510(k) Number | K080935 | |||
Device Name | SONIX MDP ULTRASOUND SCANNER | |||
Applicant |
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Applicant Contact | alan remfry | |||
Correspondent |
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Correspodent Contact | alan remfry | |||
Regulation Number | 892.1550 | |||
Classification Product Code |
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Subsequent Product Codes |
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Date Received | 04/02/2008 | |||
Decision Date | 08/06/2008 | |||
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 | No | |||
Combination Product |
No |