The following data is part of a premarket notification filed by Info-chem with the FDA for Modified Tempa-dot Thermometer.
| Device ID | K791574 |
| 510k Number | K791574 |
| Device Name: | MODIFIED TEMPA-DOT THERMOMETER |
| Classification | Thermometer, Clinical Color Change |
| Applicant | INFO-CHEM 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-13 |
| Decision Date | 1979-09-12 |