Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K002182 |
Device Name |
AVITA TSO/TS1 INFRARED EAR THERMOMETER |
Applicant |
AVITA CORPORATION |
900 N. SWITZER CANYON DR. #142 |
FLAGGSTAFF,
AZ
86001
|
|
Applicant Contact |
ALLEN REICH |
Correspondent |
AVITA CORPORATION |
900 N. SWITZER CANYON DR. #142 |
FLAGGSTAFF,
AZ
86001
|
|
Correspondent Contact |
ALLEN REICH |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 07/19/2000 |
Decision Date | 12/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|