The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Series 400 Disposable Temperature Probe.
| Device ID | K813639 |
| 510k Number | K813639 |
| Device Name: | SERIES 400 DISPOSABLE TEMPERATURE PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-31 |
| Decision Date | 1982-01-22 |