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FDA 510(k), K963064, ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
FDA 510(k), K963064, ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
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510(K) Number: K963064
Device Name: ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
Manufacturer: LABORIE MEDICAL TECH CORP.
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 08/07/1996
Decision Date: 06/05/1997
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
Manufacturer: LABORIE MEDICAL TECH CORP.
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 08/07/1996
Decision Date: 06/05/1997
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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