VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
Device Facts
| Record ID | DEN040007 |
|---|---|
| Device Name | VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER |
| Applicant | Digital Angel Corporation |
| Product Code | NRV · General Hospital |
| Decision Date | Oct 12, 2004 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 880.6300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See § 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
