Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K060649 |
Device Name |
GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 |
Applicant |
TYCO HEALTHCARE GROUP, LP |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
KEITH MARTIN |
Correspondent |
TYCO HEALTHCARE GROUP, LP |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
KEITH MARTIN |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 03/13/2006 |
Decision Date | 05/22/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|