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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K062362
Device Name SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS
Applicant
Sarmed Srl
Via Degli Artigiani, 6
Medolla,  IT 41036
Applicant Contact ANTONIO ROSSETTI
Correspondent
Sarmed Srl
Via Degli Artigiani, 6
Medolla,  IT 41036
Correspondent Contact ANTONIO ROSSETTI
Regulation Number876.1725
Classification Product Code
KLA  
Date Received08/14/2006
Decision Date 04/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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