Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K992468 |
Device Name |
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER |
Applicant |
BRAUN GMBH |
10421 PACIFIC CENTER COURT |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
LAURA GUY |
Correspondent |
BRAUN GMBH |
10421 PACIFIC CENTER COURT |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
LAURA GUY |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 07/23/1999 |
Decision Date | 10/20/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|