The following data is part of a premarket notification filed by Braun Gmbh with the FDA for Braun Thermoscan Irt 2000 Infrared Ear Thermometer.
| Device ID | K060006 |
| 510k Number | K060006 |
| Device Name: | BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BRAUN GMBH P.O. BOX 1490 Eagle, ID 83616 |
| Contact | Fred Schlador |
| Correspondent | Fred Schlador BRAUN GMBH P.O. BOX 1490 Eagle, ID 83616 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-03 |
| Decision Date | 2006-01-31 |
| Summary: | summary |