Ingestible Event Marker

Device Code: 2162

Product Code(s): OZW

Definition: To Provide Confirmation Of An Event Co-ingested Or Coincident With The Ingestible Component Of The Device. The Wearable Component Of The Device Incorporates Wireless Communication To Display The Event And Other Information On A General Computing Devi

Device Classification Information

Device Type ID2162
Device NameIngestible Event Marker
Physical StateThe System Is Composed Of An Ingestible Microsensor, A Data Recorder In The Form Of A Skin Patch, And Software
Technical MethodThe Grain-of-sand Sized Microsensor Is Designed To Communicate The Time-stamped Confirmation Of Dosing As A Unique Identifier To The Proteus Ingestion Recorder Worn On The Skin. The Ingestion Signal Is Communicated Via Volume Conduction Communication
Target AreaDigestive Tract.
Regulation DescriptionIngestible Event Marker.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number880.6305 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOZW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2162
DeviceIngestible Event Marker
Product CodeOZW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIngestible Event Marker.
CFR Regulation Number880.6305 [🔎]
Premarket Reviews
ManufacturerDecision
PROTEUS DIGITAL HEALTH, INC.
 
SUBSTANTIALLY EQUIVALENT
2
TPLC Last Update: 2019-04-02 20:06:57

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