The following data is part of a premarket notification filed by Kaz Usa, Inc (a Subsidiary Of Helen Of Troy, Inc) with the FDA for Braun Thermoscan Pro 6000 Ear Thermometer.
| Device ID | K152748 |
| 510k Number | K152748 |
| Device Name: | Braun Thermoscan PRO 6000 Ear Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC) 250 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Raj Kasbekar |
| Correspondent | Raj Kasbekar KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC) 250 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-23 |
| Decision Date | 2016-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00328785760002 | K152748 | 000 |
| 00732094325324 | K152748 | 000 |
| 00732094325089 | K152748 | 000 |
| 00732094309027 | K152748 | 000 |
| 00732094309003 | K152748 | 000 |
| 00732094325317 | K152748 | 000 |
| 00732094314649 | K152748 | 000 |