PEDIATRIC INGESTASCAN
Device Facts
| Record ID | K003305 |
|---|---|
| Device Name | PEDIATRIC INGESTASCAN |
| Applicant | Adams Electronics, Inc. |
| Product Code | HPM · Ophthalmic |
| Decision Date | Dec 22, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
