PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)

Ingestible Event Marker

PROTEUS DIGITAL HEALTH, INC.

The following data is part of a premarket notification filed by Proteus Digital Health, Inc. with the FDA for Proteus Patch, Ingestible Sensor (accessory).

Pre-market Notification Details

Device IDK131009
510k NumberK131009
Device Name:PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
ClassificationIngestible Event Marker
Applicant PROTEUS DIGITAL HEALTH, INC. 2600 BRIDGE PARKWAY, SUITE 101 Redwood City,  CA  94065
ContactJafar Shenasa
CorrespondentJafar Shenasa
PROTEUS DIGITAL HEALTH, INC. 2600 BRIDGE PARKWAY, SUITE 101 Redwood City,  CA  94065
Product CodeOZW  
CFR Regulation Number880.6305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-11
Decision Date2013-05-07
Summary:summary

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