The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Tempo2-ii Disposable Thermometers.
| Device ID | K790891 |
| 510k Number | K790891 |
| Device Name: | TEMPO2-II DISPOSABLE THERMOMETERS |
| Classification | Thermometer, Clinical Mercury |
| Applicant | AIRLIFE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-07 |
| Decision Date | 1979-06-27 |