K003305 is an FDA 510(k) clearance for the PEDIATRIC INGESTASCAN. This device is classified as a Locator, Metal, Electronic (Class II - Special Controls, product code HPM).
Submitted by Adams Electronics, Inc. (Enid, US). The FDA issued a Cleared decision on December 22, 2000, 63 days after receiving the submission on October 20, 2000.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4400.
| 510(k) Number | K003305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2000 |
| Decision Date | December 22, 2000 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HPM — Locator, Metal, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4400 |