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FDA 510(k), K012232, INSIGHT, MODEL S980000
FDA 510(k), K012232, INSIGHT, MODEL S980000
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510(K) Number: K012232
Device Name: INSIGHT, MODEL S980000
Manufacturer: SANDHILL SCIENTIFIC, INC.
Device Classification Name: system, gastrointestinal motility (electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 07/16/2001
Decision Date: 06/07/2002
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: INSIGHT, MODEL S980000
Manufacturer: SANDHILL SCIENTIFIC, INC.
Device Classification Name: system, gastrointestinal motility (electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 07/16/2001
Decision Date: 06/07/2002
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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