NRV — Implantable Radio Frequency Transponder System Class II
FDA product code NRV covers "Implantable Radio Frequency Transponder System", a Class II medical device regulated under 21 CFR 880.6300. Submissions are reviewed by the General Hospital panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NRV
- Device Class
- Class II
- Regulation Number
- 880.6300
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- Yes
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 electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN040007 | digital angel corporation | VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER | October 12, 2004 |