PYQ · Rfid Chip For Dental Appliance
General Hospital · 21 CFR 880.6300 · Class 2
Overview
| Product Code | PYQ |
|---|---|
| Device Name | Rfid Chip For Dental Appliance |
| Regulation | 21 CFR 880.6300 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170423 | DentureID Microchip | Cmp Industries, LLC | Oct 25, 2017 | SESE |
Top Applicants
- Cmp Industries, LLC — 1 clearance
