The following data is part of a premarket notification filed by Kaz Usa, Inc (a Subsidiaryof Kaz Inc) with the FDA for Braun Thermoscan Pro 4000 Series And Braun Thermoscan Irt 4000 Series Model 6021791-pro 4000 Series, 6022790-irt 4000 Se.
| Device ID | K101747 |
| 510k Number | K101747 |
| Device Name: | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KAZ USA, INC (A SUBSIDIARYOF KAZ INC) 250 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Raj Kasbekar |
| Correspondent | Raj Kasbekar KAZ USA, INC (A SUBSIDIARYOF 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 | 2010-06-22 |
| Decision Date | 2010-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094024760 | K101747 | 000 |
| 00732094024753 | K101747 | 000 |
| 00732094024593 | K101747 | 000 |
| 00732094024159 | K101747 | 000 |
| 00732094340723 | K101747 | 000 |