The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Turbo Temp Trio.
| Device ID | K050230 |
| 510k Number | K050230 |
| Device Name: | TURBO TEMP TRIO |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Contact | Stacy L Lewis |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-01 |
| Decision Date | 2005-02-16 |