K001729 is an FDA 510(k) clearance for the FOCUS. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Instrumentarium Corp. (Milwaukee, US). The FDA issued a Cleared decision on July 13, 2000, 36 days after receiving the submission on June 7, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K001729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2000 |
| Decision Date | July 13, 2000 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |