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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ingestible Event Marker
510(k) Number K150494
Device Name Proteus Digital Health Feedback Device
Applicant
Proteus Digital Health, Inc.
2600 Bridge Pkwy., Suite 101
Redwood City,  CA  94065
Applicant Contact Jessie Duong
Correspondent
Proteus Digital Health, Inc.
2600 Bridge Pkwy., Suite 101
Redwood City,  CA  94065
Correspondent Contact Jafar Shenasa
Regulation Number880.6305
Classification Product Code
OZW  
Date Received02/25/2015
Decision Date 06/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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