The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Digital Telethermometer Tth 10-200.
| Device ID | K852455 |
| 510k Number | K852455 |
| Device Name: | GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffery R Shideman |
| Correspondent | Jeffery R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-10 |
| Decision Date | 1985-09-16 |