Definition: An Implantable Microtransponder System Intended To Facilitate Access To Identification And Health Information In Humans. It Is Described As Consisting Of A Small Implantable Electronic Microtransponder, An Insertion Device (introducer), And An Electr
Device Type ID | 2696 |
Device Name | Implantable Radio Frequency Transponder System |
Regulation Description | Implantable Radiofrequency Transponder System For Patient Identification And Health Information. |
Regulation Medical Specialty | General Hospital |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 880.6300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NRV |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2696 |
Device | Implantable Radio Frequency Transponder System |
Product Code | NRV |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Implantable Radiofrequency Transponder System For Patient Identification And Health Information. |
CFR Regulation Number | 880.6300 [🔎] |