PROTEUS INGESTION CONFINMATION SYSTEMS

Ingestible Event Marker

PROTEUS BIOMEDICAL, INC.

The following data is part of a De Novo classification by Proteus Biomedical, Inc. with the FDA for Proteus Ingestion Confinmation Systems.

Pre-market Notification Details

DeNovo IDDEN120011
Device Name:PROTEUS INGESTION CONFINMATION SYSTEMS
ClassificationIngestible Event Marker
Applicant PROTEUS BIOMEDICAL, INC. 2600 Bridge Parkway suite 101 Redwood City,  CA  94065
ContactJafar Shenasa
Product CodeOZW  
CFR Regulation Number880.6305 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK113070
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGeneral Hospital
TypePost-NSE
Date Received2012-05-11
Decision Date2012-07-10
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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