510(k) DEN040007
DEN040007 is an FDA 510(k) premarket notification submitted by Digital Angel Corporation for the device "VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER". The FDA issued a decision of De Novo Granted on October 12, 2004. The device falls under product code NRV (Implantable Radio Frequency Transponder System), a Class II device regulated under 21 CFR 880.6300.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 12, 2004
- Date Received
- August 4, 2004
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implantable Radio Frequency Transponder System
- Device Class
- Class II
- Regulation Number
- 880.6300
- Review Panel
- HO
- Submission Type
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