The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Craftemp Et 3045 Electronic Thermometry System.
| Device ID | K852454 |
| 510k Number | K852454 |
| Device Name: | CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-10 |
| Decision Date | 1985-08-16 |