The following data is part of a premarket notification filed by Kaz Usa, Inc (a Subsidiary Of Kaz Inc) with the FDA for Braun Thermoscan Pro 4000 Series And Braun Thermoscan Irt 4000 Series Clinical Infrared Ear Thermometers.
| Device ID | K103800 |
| 510k Number | K103800 |
| Device Name: | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KAZ USA, INC (A SUBSIDIARY OF KAZ INC) 250 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Raj Kasbekar |
| Correspondent | Raj Kasbekar KAZ USA, INC (A SUBSIDIARY OF KAZ INC) 250 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-28 |
| Decision Date | 2011-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10328785001942 | K103800 | 000 |
| 00328785007909 | K103800 | 000 |
| 00328785004380 | K103800 | 000 |
| 00328785003796 | K103800 | 000 |
| 00328785000030 | K103800 | 000 |
| 10328785000051 | K103800 | 000 |
| 00328785000085 | K103800 | 000 |
| 10328785000099 | K103800 | 000 |
| 00328785000313 | K103800 | 000 |
| 00328785000542 | K103800 | 000 |
| 00328785001297 | K103800 | 000 |
| 10328785001911 | K103800 | 000 |
| 10328785001935 | K103800 | 000 |
| 00328785009583 | K103800 | 000 |