The following data is part of a premarket notification filed by Tyco Healthcare Group, Lp with the FDA for Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000.
| Device ID | K060649 |
| 510k Number | K060649 |
| Device Name: | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TYCO HEALTHCARE GROUP, LP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Keith Martin |
| Correspondent | Keith Martin TYCO HEALTHCARE GROUP, LP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-13 |
| Decision Date | 2006-05-22 |
| Summary: | summary |