information about
Device Classification Name |
system, imaging, pulsed doppler, ultrasonic |
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510(k) Number | K002239 | |||
Device Name | SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM | |||
Original Applicant |
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Original Contact | george myers | |||
Regulation Number | 892.1550 | |||
Classification Product Code |
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Subsequent Product Code |
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Date Received | 07/24/2000 | |||
Decision Date | 08/08/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Radiology |
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510k Review Panel |
Radiology |
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Type | Traditional | |||
Reviewed by Third Party | Yes | |||
Combination Product |
No |