K843951 is an FDA 510(k) clearance for the SIROGNATHOGRAPH. This device is classified as a Device, Jaw Tracking, For Monitoring Jaw Positions (Class I - General Controls, product code NFS).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on November 14, 1984, 36 days after receiving the submission on October 9, 1984.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.2060.
| 510(k) Number | K843951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1984 |
| Decision Date | November 14, 1984 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | NFS — Device, Jaw Tracking, For Monitoring Jaw Positions |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.2060 |