FDA 510(k) Application Details - K010130

Device Classification Name System, Gastrointestinal Motility (Electrical)

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510(K) Number K010130
Device Name System, Gastrointestinal Motility (Electrical)
Applicant MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
16-18 TONSBAKKEN
SKOVLUNDE DK-2740 DK
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Contact TOVE KJAER
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Regulation Number 876.1725

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Classification Product Code FFX
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Date Received 01/16/2001
Decision Date 02/07/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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