Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K042906 |
Device Name |
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 |
Applicant |
AMPLIFE CORPORATION |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
N.E. DEVINE JR. |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 10/21/2004 |
Decision Date | 11/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|