K800491 is an FDA 510(k) clearance for the GRAPHIC STRESS TELETHERMOMETRY. This device is classified as a System, Telethermographic, Infrared (Class III - Premarket Approval, product code IYM).
Submitted by Gst Laboratories of Ca, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1980.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K800491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | March 04, 1980 |
| Decision Date | March 04, 1980 |
| Days to Decision | — |
| 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 |