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 | ||
|---|---|---|
| Manufacturer | Decision | |
PROTEUS DIGITAL HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |