The following data is part of a premarket notification filed by Temp-stik Corp. with the FDA for Three Second Thermometer #ts-1000.
| Device ID | K820948 |
| 510k Number | K820948 |
| Device Name: | THREE SECOND THERMOMETER #TS-1000 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TEMP-STIK CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-06 |
| Decision Date | 1982-09-24 |