K823041 is an FDA 510(k) clearance for the JEOL MODEL #JTG-500M. This device is classified as a System, Telethermographic, Infrared (Class III - Premarket Approval, product code IYM).
Submitted by Jeol (Mchenry, US). The FDA issued a Cleared decision on November 24, 1982, 41 days after receiving the submission on October 14, 1982.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K823041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1982 |
| Decision Date | November 24, 1982 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYM — System, Telethermographic, Infrared |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 884.2980 |