K013237 is an FDA 510(k) clearance for the STATUSBLUE. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on October 22, 2001, 24 days after receiving the submission on September 28, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K013237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2001 |
| Decision Date | October 22, 2001 |
| Days to Decision | 24 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |