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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 K183052
Device Name ID-Cap System
Applicant
Etectrx, Inc.
747 SW 2nd Ave.
Suite 365t, Imb 24
Gainesville,  FL  32601
Applicant Contact Susan Baumgartner
Correspondent
Etectrx, Inc.
747 SW 2nd Ave.
Suite 365t, Imb 24
Gainesville,  FL  32601
Correspondent Contact Paul Dryden
Regulation Number880.6305
Classification Product Code
OZW  
Date Received11/02/2018
Decision Date 12/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02344238
NCT02344251
NCT03475485
NCT03653897
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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