PROTEUS PATCH, PROTEUS 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, Proteus Ingestible Sensor (accessory).

Pre-market Notification Details

Device IDK133263
510k NumberK133263
Device Name:PROTEUS PATCH, PROTEUS 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 Received2013-10-23
Decision Date2014-02-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10856602005014 K133263 000
10856602005045 K133263 000
10856602005052 K133263 000
10856602005069 K133263 000
10856602005076 K133263 000
10856602005083 K133263 000
10856602005090 K133263 000
10856602005106 K133263 000
10856602005113 K133263 000
10856602005120 K133263 000
10856602005021 K133263 000

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