The following data is part of a premarket notification filed by Braun Gmbh with the FDA for Braun Thermoscan Pro 4000 Series (professional Use Environment); Braun Thermoscan Irt 4000 Series (home Use Environment).
| Device ID | K031928 |
| 510k Number | K031928 |
| Device Name: | BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BRAUN GMBH 6183 PASEO DEL MORTE SUITE 150 Carlsbad, CA 92009 |
| Contact | Fred Schlador |
| Correspondent | Fred Schlador BRAUN GMBH 6183 PASEO DEL MORTE SUITE 150 Carlsbad, CA 92009 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2003-10-24 |
| Summary: | summary |