Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K002712 |
Device Name |
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F |
Applicant |
S.A.A.T., LTD. |
117 AHUZAH ST. |
PUSH-MED LTD |
RA'ANANNA,
IL
43373
|
|
Applicant Contact |
SHOSHANA FRIEDMAN |
Correspondent |
S.A.A.T., LTD. |
117 AHUZAH ST. |
PUSH-MED LTD |
RA'ANANNA,
IL
43373
|
|
Correspondent Contact |
SHOSHANA FRIEDMAN |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 02/08/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|