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 Type ID | 2162 |
Device Name | Ingestible Event Marker |
Physical State | The System Is Composed Of An Ingestible Microsensor, A Data Recorder In The Form Of A Skin Patch, And Software |
Technical Method | The 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 Area | Digestive Tract. |
Regulation Description | Ingestible Event Marker. |
Regulation Medical Specialty | General Hospital |
Review Panel | Gastroenterology/Urology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
Submission Type | 510(k) |
CFR Regulation Number | 880.6305 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | OZW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2162 |
Device | Ingestible Event Marker |
Product Code | OZW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Ingestible Event Marker. |
CFR Regulation Number | 880.6305 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
PROTEUS DIGITAL HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 |