K811211 is an FDA 510(k) clearance for the YOSHIDA AP 100. This device is classified as a Processor, Radiographic-film, Automatic, Dental (Class II - Special Controls, product code EGY).
Submitted by Kaycor Intl., Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981, 43 days after receiving the submission on May 4, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K811211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1981 |
| Decision Date | June 16, 1981 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | EGY — Processor, Radiographic-film, Automatic, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |