K801553 is an FDA 510(k) clearance for the THERMOCOMP. This device is classified as a System, Telethermographic, Infrared (Class III - Premarket Approval, product code IYM).
Submitted by Hospital Financial Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 115 days after receiving the submission on July 8, 1980.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K801553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1980 |
| Decision Date | October 31, 1980 |
| Days to Decision | 115 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 |