The following data is part of a premarket notification filed by Braun Gmbh with the FDA for Braun Thermoscan Pro3000 Infared Thermometer.
Device ID | K992468 |
510k Number | K992468 |
Device Name: | BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | BRAUN GMBH 10421 PACIFIC CENTER COURT San Diego, CA 92121 |
Contact | Laura Guy |
Correspondent | Laura Guy BRAUN GMBH 10421 PACIFIC CENTER COURT San Diego, CA 92121 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-23 |
Decision Date | 1999-10-20 |
Summary: | summary |