The following data is part of a premarket notification filed by Braun Ag with the FDA for Braun Thermoscan Irt3020/3500 One Secons Ear Thermometer, Model Irt3020/3520.
| Device ID | K983295 |
| 510k Number | K983295 |
| Device Name: | BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BRAUN AG 10421 PACIFIC CENTER COURT San Diego, CA |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison BRAUN AG 10421 PACIFIC CENTER COURT San Diego, CA |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1999-03-15 |
| Summary: | summary |