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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autonomous Extracorporeal Blood Leak Detector/Alarm
510(k) Number K130554
Device Name REDSENSE ALARM SYSTEM
Applicant
Redsense Medical AB
Gyllenhammars Vag 26
Halmstad,  SE 30292
Applicant Contact PATRIK BYHMER
Correspondent
Redsense Medical AB
Gyllenhammars Vag 26
Halmstad,  SE 30292
Correspondent Contact PATRIK BYHMER
Regulation Number876.5820
Classification Product Code
ODX  
Date Received03/04/2013
Decision Date 11/22/2013
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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