The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Model 2100 Dual-display Tele-thermometer.
| Device ID | K813409 |
| 510k Number | K813409 |
| Device Name: | MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 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 | 1981-12-04 |
| Decision Date | 1981-12-18 |